| Joint US FDA – Health Canada ICH Public Meeting 2025 | Webinar | 2/11/2025 | Bioequivalence, Generic Drug Development, Good Clinical Practice, International, New Drug Development, Pediatric, Stability | No |
| Improving Data Quality with Centralized Statistical Monitoring with Dr. Paul Schuette and Xiaofeng (Tina) Wang | SBIA Chronicles Podcast | 12/13/2024 | Statistical Analysis | No |
| Generic Drugs Forum (GDF) 2025 | Conference | 4/9/2025 | ANDA, Bioequivalence, Generic Drug Development | No |
| Knowledge Management and Modernization of Regulatory Quality Assessment and Submissions at FDA | Conference | 1/28/2025 | ANDA; BLA; Chemistry, Manufacturing and Controls (CMC); Clinical Trials and Research; Drug Master Files (DMF); IND; Knowledge-aided Assessment and Structured Application (KASA); NDA; New Drug Development; Pharmaceutical Quality; Quality Assessments | No |
| BsUFA III Regulatory Science Pilot Program: Progress Update | Webinar | 1/22/2025 | BLA; Biologics; Biosimilars; International; Regulatory Science | No |
| FDA Clinical Investigator Training Course (CITC) 2024 | Conference | 12/10/2024 | Chemistry Manufacturing and Controls (CMC), Clinical Trials and Research, Digital Health Technologies, Drug Safety, Good Clinical Practice, IND, Inspections, International, New Drug Development, Real World Evidence | No |
| Clinical Pharmacology Considerations for Novel Therapeutic Modalities | Webinar | 12/4/2024 | Antibody Drug Conjugates, Clinical Pharmacology, Clinical Trials and Research, Drug Safety, IND, International, New Drug Development, Oligonucleotide Therapeutics | No |
| M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance | Webinar | 11/21/2024 | ANDA, Bioequivalence, Generic Drug Development, International | No |
| The Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert Ball | SBIA Chronicles Podcast | 11/14/2024 | Artificial Intelligence | No |
| Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies | Webinar | 11/12/2024 | Clinical Pharmacology, Clinical Trials and Research, Drug Safety, IND, International, New Drug Development, Radiolabeled Mass Balance | No |
| Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation | Webinar | 11/7/2024 | ANDA, BLA, Drug Safety, New Drug Development, Risk Management, Risk Evaluation and Mitigation Strategy (REMS) | No |
| Global IDMP Implementation - Getting Closer to the Goal | Webinar | 10/16/2024 | Data Standards, Drug Shortages, Labeling, Electronic Submissions, Pharmacovigilance, Regulatory Submissions | No |
| ICH M12 Drug-Drug Interaction Studies Final Guidance | Webinar | 10/9/2024 | Drug Interaction, New Drug Development, IND | No |
| Advancing Generic Drug Development: Translating Science to Approval 2024 | Conference/Workshop | 9/24/2024 | ANDA, Complex Generic Drug, Product Specific Guidances, Generic Drug Development, Regulatory Assessment | No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024 | Conference/Workshop | 9/12/2024 | Import/Export, International, Registration and Listing | No |
| ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA | Webinar | 9/10/2024 | ANDA, Generic Drug Development, Regulatory Submissions | No |
| FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA | Webinar | 9/4/2024 | Biologics, Chemistry, Manufacturing, and Controls (CMC), Clinical Trials and Research, Early Product Development, Devices, Digital Health Technologies, Drug Development | No |
| Environmental Monitoring in Compounding | Webinar | 7/30/2024 | Compounding, Environmental Monitoring, Outsourcing Facilities | No |
| Dataset-JSON Pilot Report and Next Steps | Webinar | 7/25/2024 | Data Standards, International, Regulatory Science, Regulatory Submissions | No |
| Introduction to FDA’s Office of Trade and Global Partnerships | Webinar | 7/23/2024 | Combination Products, Drug Supply, International Trade | No |
| Office of Pharmaceutical Quality (OPQ) Reorganization | On Demand | 7/16/2024 | Drug Quality, Emerging Technology, International, Manufacturing, Quality Assessments, Supply Chain | No |
| Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule | Webinar | 6/26/2024 | Advertising, Marketing, Regulatory Submissions | No |
| OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration | Webinar | 6/18/2024 | OTC Regulation, User Fees | No |
| OSIS Workshop: CDER Inspections of Good Laboratory Practice and Bioavailability/Bioequivalence Study Sites | Webinar | 6/13/2024 | Animal Rule, Bioanalysis, Bioavailability, Bioequivalence, Clinical Trials and Research, Good Laboratory Practice | No |
| Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development | Conference/Workshop | 5/29/2024 | Advanced Manufacturing, Artificial Intelligence, Biologics, Clinical Trials and Research, Combination Products, Devices, Drug Safety, Drug Supply Chain, Electronic Submissions, New Drug Development | No |
| Considerations for Drug Products that Contain Nanomaterials | SBIA Chronicles Podcast | 5/17/2024 | Nanomaterials | No |
| Considerations for Drug Products that Contain Nanomaterials | SBIA Chronicles | 5/17/2024 | Nanomaterials | No |
| Statistical Considerations for Premarketing Risk Assessment | Webinar | 5/16/2024 | Clinical Trials and Research, New Drug Development, Integrated Safety Analyses | No |
| Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval | Webinar | 5/9/2024 | ANDA, Generic Drug Development, Meetings, Regulatory Assessments | No |
| Facilitating Generic Drug Product Development through Product-Specific Guidances | Webinar | 4/25/2024 | ANDA, Bioequivalence, Generic Drug Development, Product Specific Guidances | No |
| Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access | Conference/Workshop | 4/10/2024 | ANDA, Bioequivalence, Chemistry Manufacturing and Controls (CMC), Controlled Correspondence, Generic Drug Development, Meetings, Product Specific Guidances | No |
| Expanding Generic Drug Access Through International Engagements | Webinar | 2/28/2024 | ANDA, Bioequivalence, Clinical Trials and Research, Complex Generic Drug, Generic Drug Development, International | No |
| Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes | Webinar | 3/7/2024 | Clinical Trials and Research, New Drug Development, Integrated Safety Analyses | No |
| Joint US FDA – Health Canada ICH Public Meeting | Webinar | 2/22/2024 | International, New Drug Development, Generic Drug Development, Safety, Real Word Evidence, Analytical Validation, Drug Safety, Data Management | No |
| A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs | Webinar | 1/18/2024 | Generic Drug Development, Bioequivalence, ANDA, Meetings | No |
| eCTD (7/28) Generic Drugs Forum 201 | Webinar | 4/4/2017 | ANDA, Generic Drug Development, Regulatory Submissions | Disponible/Available |
| Introduction to “The ANDA Review Pathway” (11/28) Generic Drugs Forum 2017 | Webinar | 4/4/2017 | ANDA, Generic Drug Development, Regulatory Submissions | Disponible/Available |
| FDA’s Bioequivalence Recommendations for Generic Drugs (16/28) Generic Drugs Forum 2017 | Webinar | 4/4/2017 | ANDA, Bioequivalence, Generic Drug Development, Regulatory Assessment | Disponible/Available |
| Manufacturing Process and Controls (25/28) Generic Drugs Forum 2017 | Webinar | 4/4/2017 | ANDA, Chemistry Manufacturing and Contgrols (CMC), Drug Quality, Generic Drug Development | Disponible/Available |
| Drug Master Files (DMFs) from an ANDA Perspective (7of28) Generic Drugs Forum – Apr. 3-4, 2019 | Webinar | 4/3/2019 | ANDA, Drug Master Files, Generic Drug Development, Regulatory Assessment, Regulatory Submissions | Disponible/Available |
| Orange Book - Its Role in ANDAs (8of28) Generic Drugs Forum – Apr. 3-4, 2019 | Webinar | 4/3/2019 | ANDA;Generic Drug Development; New Drug Development; Orange Book | Disponible/Available |
| Product Specific Guidances (PSGs) Generic Drugs Forum 2020 | Webinar | 4/15/2020 | ANDA; Complex Generic Drug; Generic Drug Development; Product Specific Guidances | Disponible/Available |
| Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020 | Webinar | 6/30/2020 | Manufacturing; Regulatory Submissions | Disponible/Available |
| FDA Drug Manufacturing Inspections - REdI 2020 | Webinar | 6/30/2020 | Manufacturing; Inspections; Regulatory Submissions | Disponible/Available |
| ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues | Webinar | 4/28/2021 | ANDA; Generic Drug Development; Quality Assessments | Disponible/Available |
| A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium | Symposium | 2/13/2024 | New Drug Development, Clinical Trials and Research, ANDA, Bioequivalence, BLA, Digital Health Technologies, International, Regulatory Assessment, Inspections | No |
| Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources | Webinar | 12/12/2023 | IND, Labeling, Drug Interaction, Therapeutic Protein | No |
| FDA Clinical Investigator Training Course (CITC) 2023 | Conference/Workshop | 12/6/2023 | IND, Clinical Trials and Research, New Drug Development, Real World Evidence, International, Digital Health Technologies | No |
| Toward Global IDMP Implementation: A Focus on Global Use Cases | Webinar | 11/28/2023 | Regulatory Submissions, Data Standards | No |
| Common Issues with SEND Data Submitted for Safety Pharmacology Studies | Webinar | 11/16/2023 | Regulatory Submissions, Data Standards | No |
| Implementing DSCSA: Stabilization Period and Expectations | Webinar | 11/3/2023 | DCSA, Compliance, Drug Supply Chain, Wholesaler, Distributor, Unique Serial Numbers | No |
| Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing | Symposium | 10/31/2023 | Drug Quality, Quality Assessments, Supply Chain, Manufacturing, Emerging Technology | No |
| BsUFA III Regulatory Science Pilot Program | Webinar | 10/16/2023 | Biomarkers, Regulatory Science, BLA, Biologics | No |
| 2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials | Symposium | 10/11/2023 | Generic Drug Development, New Drug Development, IND, NDA, BLA, ANDA, Nanomaterials, Non-Clinical, Quality Assessment, Continuous Manufacturing, Regulatory Science, Delivery System, Lipid, Liposome | No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2023 | Conference/Workshop | 9/28/2023 | Registration and Listing, Import/Export | No |
| Use of Biomarkers for Diagnosing and Assessing Treatment Response in Noncirrhotic NASH Trials | Conference/Workshop | 9/18/2023 | Clinical Trials and Research, New Drug Development, Biomarkers, Surrogate Endpoints, Noninvasive tests, Noncirrhotic NASH | No |
| Advancing Generic Drug Development: Translating Science to Approval 2023 | Conference/Workshop | 9/13/2023 | ANDA, Generic Drug Development, Complex Generic Drug, Product Specific Guidances, Regulatory Assessment | No |
| Understanding FDA Inspections and Data | Webinar | 9/6/2023 | Inspections, International, Current Good Manufacturing Practice (CGMP) | No |
| OTC Monograph Reform: OMOR Format and Content & Electronic Submissions | Webinar | 8/22/2023 | OTC Drug Regulation, Regulatory Submissions, ANDA, NDA, New Drug Development | No |
| Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products | SBIA Chronicles Podcast | 8/17/2023 | Clinical Trials and Research | No |
| Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products | SBIA Chronicles | 8/17/2023 | Clinical Trials and Research | No |
| ClinicalTrials.gov – a Three-Part Series | Webinar | 8/9/2023 | ClinicalTrials.gov, Clinical Trials and Research | No |
| Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products | SBIA Chronicles | 7/11/2023 | Generic Drug Development | No |
| Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products | SBIA Chronicles Podcast | 7/11/2023 | Generic Drug Development | No |
| Decentralized Clinical Trials (DCT) Draft Guidance | Webinar | 6/20/2023 | Clinical Trials and Research, IND, New Drug Development | No |
| Overview: Clinical Pharmacology Considerations for Food Effect Studies | Webinar | 6/15/2023 | Drug Development, Regulatory Submissions | No |
| Regulatory Education for Industry (REdI) Annual Conference 2023 | Conference/Workshop | 6/5/2023 | BLA, Chemistry Manufacturing and Controls (CMC), Digital Health Technologies, Drug Development, FDA Meetings/Communications, IND, NDA, New Drug Development, Real World Evidence, and Regulatory Submissions | No |
| An Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR) | Webinar | 5/24/2023 | Drug Quality, Regulatory Submissions, and Quality Assessments | No |
| OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration | Webinar | 5/16/2023 | OTC Drug Regulation, User Fees | No |
| A Deep Dive: GDUFA III Scientific Meetings | Webinar | 5/15/2023 | ANDA, Generic Drug Development, FDA Meetings/Communications | No |
| Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms” | Webinar | 5/2/2023 | Generic Drug Development, International | No |
| Electronic Systems, Electronic Records, and Electronic Signatures Webinar | Webinar | 4/25/2023 | New Drug Development, Clinical Trials and Research, IND | No |
| FDA’s Dosage and Administration Section of Labeling Draft Guidance | Webinar | 4/19/2023 | Labeling | No |
| The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development | SBIA Chronicles Podcast | 4/10/2023 | Biosimilars | No |
| The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development | SBIA Chronicles | 4/10/2023 | Biosimilars | No |
| Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF | Conference/Workshop | 4/7/2023 | Generic Drug Development | No |
| A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence | Webinar | 3/14/2023 | Bioequivalence, Generic Drug Development, Drug Development | No |
| Joint US FDA – Health Canada ICH Public Meeting | Webinar | 2/24/2023 | Clinical Trials and Research, International, New Drug Development | No |
| Overview: Clinical Pharmacology Considerations for Neonatal Studies | Webinar | 2/15/2023 | Clinical Trials and Research, IND, NDA, BLA, New Drug Development | No |
| FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds | SBIA Chronicles | 2/6/2023 | Drug Quality | No |
| FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds | SBIA Chronicles Podcast | 2/6/2023 | Drug Quality | No |
| Overview of FDA’s Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use | Webinar | 2/1/2023 | OTC Drug Regulation | No |
| FDA’s Labeling Resources for Human Prescription Drugs | Webinar | 1/26/2023 | Labeling | No |
| Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards | Webinar | 1/13/2023 | Regulatory Submissions, Safety | No |
| What to Expect after an Inspection: 483s, Responses and Beyond | Webinar | 12/14/2022 | Compliance, Compounding, Inspections, FDA Form 483 | No |
| FDA Clinical Investigator Training Course (CITC) 2022 | Conference/Workshop | 12/7/2022 | IND, Clinical Trials and Research, New Drug Development, Real World Evidence, International, Digital Health Technologies | No |
| Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions | Conference/Workshop | 11/30/2022 | ANDA, Drug Master Files, Generic Drug Development, Regulatory Submissions, Quality Assessments | No |
| Proposed Rule: Revising the National Drug Code Format and Drug Label Barcode Requirements | Webinar | 11/17/2022 | Registration and Listing | No |
| An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations | Webinar | 10/26/2022 | Drug Development, New Drug Development, Bioequivalence, Bioavailability, IND, NDA | No |
| FDA NanoDay Symposium 2022 | Symposium | 10/11/2022 | Generic Drug Development, New Drug Development, IND, NDA, Chemistry Manufacturing and Controls (CMC), Nanomaterials, Non-Clinical, ANDA | No |
| Study Data Standards Update for CBER: Your Guide to a Successful Submission | Webinar | 10/6/2022 | Data Standards, Regulatory Submissions | No |
| The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities | SBIA Chronicles | 9/29/2022 | Compounding | No |
| The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities | SBIA Chronicles Podcast | 9/29/2022 | Compounding | No |
| Advancing Generic Drug Development: Translating Science to Approval | Conference/Workshop | 9/20/2022 | Generic Drug Development, Drug Quality, Regulatory Submissions | No |
| Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act | Webinar | 9/8/2022 | Registration and Listing | No |
| Regulatory Best Practices for Global Access to Medicines, Including Anti-TB Medicines | Conference/Workshop | 8/16/2022 | Drug Development, Drug Quality, Generic Drug Development, New Drug Development, IND, International, Post Approval | No |
| Best Practices for Topical Generic Product Development and ANDA Submission | Webinar | 8/11/2022 | Generic Drug Development | No |
| Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use | Webinar | 8/10/2022 | Generic Drug Development | No |
| Office of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites | Conference/Workshop | 7/19/2022 | Drug Development, Inspections, New Drug Development, IND | No |
| An FDA Self-Audit of Continuous Manufacturing for Drug Products | SBIA Chronicles | 6/28/2022 | Drug Quality | No |
| An FDA Self-Audit of Continuous Manufacturing for Drug Products | SBIA Chronicles Podcast | 6/28/2022 | Drug Quality | No |
| Regulatory Education for Industry (REdI) Annual Conference 2022 | Conference/Workshop | 6/6/2022 | Biosimilars, Drug Development, DSCSA, FDA Meetings/Communications, Inspections, NDA, New Drug Development, Regulatory Submissions, Resources, Safety | No |
| Quality Management Maturity Workshop | Webinar | 5/24/2022 | Drug Quality | No |
| US-Canada Regional ICH Consultation | Webinar | 5/11/2022 | Clinical Trials and Research; International; New Drug Development | No |
| FDA Workshop on the Role of Phytosterols in PNALD/IFALD | Webinar | 5/6/2022 | Drug Development | No |
| Generic Drugs Forum 2022: The Current State of Generic Drugs | Conference/Workshop | 4/26/2022 | Generic Drug Development | No |
| The Key Elements of Being “Recall-Ready” | CDER SBIA Chronicles | 4/20/2022 | Recalls | No |
| The Key Elements of Being "Recall-Ready" | CDER SBIA Chronicles Podcast | 4/20/2022 | Recalls | No |
| Proposed Rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers | Webinar | 4/13/2022 | DSCSA | No |
| FDA Inspections of Outsourcing Facilities | Webinar | 4/6/2022 | Compounding, Inspections | No |
| Immunogenicity Information in Labeling | Webinar | 4/5/2022 | Drug Development, Labeling | No |
| OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings | Webinar | 3/29/2022 | OTC Drug Regulation, Clinical Trials and Research, Regulatory Submissions, FDA Meetings/Communications | No |
| FDA-EMA Parallel Scientific Advice (PSA) Program | Webinar | 3/16/2022 | New Drug Development, Drug Development, International, Regulatory Submissions | No |
| Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA | Webinar | 2/24/2022 | Drug Development, Generic Drug Development | No |
| CDER BIMO GCP Compliance and Enforcement | Webinar | 2/16/2022 | Clinical Trials and Research, Inspections, New Drug Development | No |
| Digital Health Technologies (DHTs) for Remote Data Acquisition Draft Guidance | Webinar | 2/10/2022 | New Drug Development, Clinical Trials and Research, IND | No |
| Toward Global Identification of Medicinal Products (IDMP) Implementation: A Focus on Biologics | Webinar | 1/27/2022 | New Drug Development, Labeling, Post Approval, Clinical Trials and Research | No |
| OTC Monograph Reform: Deemed Final Orders | Webinar | 12/15/2021 | OTC Drug Regulation | No |
| OTC Monograph Reform: OTC Sunscreen Drugs | Webinar | 12/15/2021 | OTC Drug Regulation | No |
| Clinical Investigator Training Course (CITC) Update | Webinar | 12/7/2021 | Clinical Trials and Research, New Drug Development | No |
| Pharmaceutical Quality Symposium 2021: Innovations in a Changing World | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Pharmaceutical Quality Symposium 2021 Part 1 with Keynote Addresses | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Pharmaceutical Quality Symposium 2021 Part 2, FDA Leaders Panel Discussion | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Pharmaceutical Quality Symposium 2021 Part 3 Panel Questions and Discussion | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Pharmaceutical Quality Symposium 2021 Part 4 | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Pharmaceutical Quality Symposium 2021 Part 5 | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Pharmaceutical Quality Symposium 2021 Part 6 | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Pharmaceutical Quality Symposium 2021 Part 7 | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Pharmaceutical Quality Symposium 2021 Part 8 | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 1 with Keynote Address | Conference/Workshop | 10/13/2021 | Registration and Listing | No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 2 | Conference/Workshop | 10/13/2021 | Registration and Listing | No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 3 | Conference/Workshop | 10/13/2021 | Registration and Listing | No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 4 with Closing Remarks | Conference/Workshop | 10/13/2021 | Registration and Listing | No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct | Conference/Workshop | 10/13/2021 | Registration and Listing | No |
| Webinar | 10/5/2021 | DSCSA | No |
| Investigator Responsibilities — Safety Reporting for Investigational Drugs and Device | Webinar | 9/29/2021 | IND, Safety | No |
| Advancing Generic Drug Development: Translating Science to Approval | Conference/Workshop | 9/21/2021 | Generic Drug Development | No |
| Advancing Generic Drug Development: Translating Science to Approval Keynote Address | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| COVID-19 Impact on Generic Drug Regulation and Evaluation + QA | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Considerations in Assessing Generic Drug Products of Oral Dosage Forms + QA | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Complex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 1 + QA | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Complex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 2 + QA | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Advancing Generic Drug Development: Translating Science to Approval, Day One Closing Remarks | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Cutting Edge Science in Complex Generics + QA | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Complex Generics_Nasal and Inhalation Products + QA | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Complex Generics_Topical Products, Part 1 + QA | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Complex Generics_Topical Products, Part 2 + QA | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Advancing Generic Drug Development: Translating Science to Approval, Day Two Closing Remarks | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| The ABCs of Product Specific Guidances | CDER SBIA Chronicles | 9/2/2021 | Generic Drug Development | No |
| The ABCs of Product Specific Guidances | CDER SBIA Chronicles Podcast | 9/2/2021 | Generic Drug Development | No |
| Promotional Submissions in eCTD Format – Grouped Submissions | Webinar | 8/31/2021 | Regulatory Submissions | No |
| Manufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency | Webinar | 8/25/2021 | Inspections; Drug Quality; DSCSA | No |
| Regulatory Education for Industry (REdI) Annual Conference 2021 | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| 2021 REdI Conference Keynote Address by Janet Woodcock, MD | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| 2021 REdI Conference Plenary Session with Patrizia Cavazzoni, MD | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| OND Reorganization and the New Drugs Regulatory Program Modernization | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| ANDA Efforts Related to COVID-19 | Conference/Workshop | 7/19/2021 | Generic Drug Development | No |
| Resource Capacity Planning: How CDER is Modernizing Resource Planning Capabilities | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| CDER NextGen Portal | Conference/Workshop | 7/19/2021 | Regulatory Submissions | No |
| Electronic Common Technical Document (eCTD) | Conference/Workshop | 7/19/2021 | Regulatory Submissions | No |
| Product Quality Consideration for Emergency Use Authorizations (EUAs) | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| Strategies to Address Potential Medication Errors for EUA Products for COVID-19 | Conference/Workshop | 7/19/2021 | New Drug Development; Safety | No |
| Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| CDER’s Role in Public Health Emergency Response and Medical Countermeasure Development | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| Where Do We Go from Here? How the Ombudsman Can Help | Conference/Workshop | 7/19/2021 | FDA Meetings/Communications | No |
| Communication Best Practices – Interacting with Regulatory Project Managers in CDER/ORO | Conference/Workshop | 7/19/2021 | FDA Meetings/Communications | No |
| Communications in a Global Pandemic | Conference/Workshop | 7/19/2021 | FDA Meetings/Communications | No |
| Regulatory Policy: Role in Guiding Decision Making in CDER | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| Role of the Product Jurisdiction Team in the Medical Product Development Process | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| FDA Guidance on Conduct of Clinical Trials of Medical Products During the Public Health Emergency | Conference/Workshop | 7/19/2021 | New Drug Development; Clinical Trials and Research | No |
| OSI’s Role in the Drug Development Process and Impact of COVID-19 | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies | Webinar | 6/29/2021 | IND, Safety | No |
| Identification of Medicinal Products: Path to Global Implementation | Webinar | 6/11/2021 | International, Labeling, Regulatory Submissions | No |
| OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees Webinar | Webinar | 6/3/2021 | OTC Drug Regulation | No |
| FDA Study Data Technical Rejection Criteria (TRC): What you need to know! | Webinar | 5/21/2021 | Regulatory Submissions | No |
| FY 2021 Generic Drug Science and Research Initiatives Public Workshop | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Welcome, Keynote, and Industry Survey Results - GDUFA Science and Research Initiatives Public Workshop | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Generic Industry Challenge Perspectives - GDUFA Science and Research Initiatives Public Workshop | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Public Comment - GDUFA Science and Research Initiatives Public Workshop | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Panel Discussion with Generic Industry - GDUFA Science and Research Initiatives Public Workshop | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Model-Integrated Evidence for Generic Drug Development – Session 1A | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Model-Integrated Evidence for Generic Drug Development – Session 1B | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Model-Integrated Evidence for Generic Drug Development – Session 1C | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Complex Product Characterization/Analysis - Session 2A | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Complex Product Characterization/Analysis - Session 2B | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Complex Product Characterization/Analysis - Session 2C | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3A | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3B | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Closing Remarks - Robert Lioberger, PhD, Director, Office of Research and Standards (ORS), OGD, FDA | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| FDA and Health Canada Regional ICH Consultation | Conference/Workshop | 5/14/2021 | Clinical Trials and Research; International; New Drug Development | No |
| FDA and Health Canada Regional ICH Consultation - Part I | Conference/Workshop | 5/14/2021 | Clinical Trials and Research; International; New Drug Development | No |
| FDA and Health Canada Regional ICH Consultation - Part II | Conference/Workshop | 5/14/2021 | Clinical Trials and Research; International; New Drug Development | No |
| Common Labeling Deficiencies and Tips for Generic Drug Applications | Webinar | 5/7/2021 | Generic Drug Development; Labeling | No |
| FDA Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs | Webinar | 5/5/2021 | Generic Drug Development; New Drug Development; Orange Book | No |
| Generic Drugs Forum 2021: Lifecycle of a Generic Drug | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Generic Drugs Forum 2021: Lifecycle of a Generic Drug: Keynote from Sally Choe, Director, Office of Generic Drugs (OGD) | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Office of Pharmaceutical Quality (OPQ) Update | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Global Generic Drug Landscape | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Data Integrity Issues in Bioequivalence Studies | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Bioavailability/Bioequivalence Site Evaluation During the Pandemic | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Impact of Data Integrity Issues on Pharmacology/Toxicology Studies in ANDAs | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Generic Drugs Forum 2021: Panel Discussion 1 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| OPQ Policy Update | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Update on CDER’s Quality Management Maturity Program | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Generic Drugs Forum 2021: Panel Discussion 2 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Pre-ANDA Program | Conference/Workshop | 4/28/2021 | Generic Drug Development; FDA Meetings/Communications | No |
| Pre-ANDA Program Update and Tips for Success – OPQ Perspective | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Controlled Correspondence Related to Pharmaceutical Quality | Conference/Workshop | 4/28/2021 | Generic Drug Development; FDA Meetings/Communications | No |
| Generic Drugs Forum 2021: Panel Discussion 3 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Division of Filing Review: Helpful Tips for Submission of an ANDA or Controlled Correspondence | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| >ANDA Labeling: Recommendations and Helpful Resources | Conference/Workshop | 4/28/2021 | Generic Drug Development; Labeling | No |
| Generic Drugs Forum 2021: Panel Discussion 4 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Addressing Common Challenges in BE Studies Due to COVID-19: OGD’s Approach | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Insights from Records Requests under §704(a)(4) of the FD&C Act in lieu of Pre-Approval Inspections | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Generic Drugs Forum 2021: Panel Discussion 5 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Mid-Review Cycle Meeting Overview | Conference/Workshop | 4/28/2021 | Generic Drug Development; FDA Meetings/Communications | No |
| Information to Include with Cover Letters | Conference/Workshop | 4/28/2021 | Generic Drug Development; FDA Meetings/Communications | No |
| Application Communications – Quality Assessment Perspective | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Generic Drugs Forum 2021: Panel Discussion 6 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Fostering Innovation Through OPQ’s Emerging Technology Program | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Lab Science to Support Generic Complex Drug Product Assessment | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Assessment of Extractables/Leachables Data in ANDA Submissions | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Generic Drugs Forum 2021: Panel Discussion 7 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Integrated Manufacturing Assessment: Expectations | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Building a Better Sterility Assurance Application | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Generic Drugs Forum 2021: Panel Discussion 8 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Postmarketing Safety and Surveillance of Generic Drugs Update | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Premarket Review of Expedited Serious Adverse Event Reports of BA/BE Studies | Conference/Workshop | 4/28/2021 | Generic Drug Development; Safety | No |
| Update on Shared System REMS for Generic Drug | Conference/Workshop | 4/28/2021 | Generic Drug Development; Safety | No |
| ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Generic Drugs Forum 2021: Panel Discussion 9 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Drug Master File (DMF) and Drug Substance Question and Answer Webinar Following March 3-4, 2021 Workshop | Webinar | 4/9/2021 | Drug Master Files | No |
| FDA Safety Report Type Flag Requirement for FAERS Submissions | Webinar | 2/19/2021 | Regulatory Submissions; Safety | No |
| Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Oncology Center of Excellence Introduction and Overview of the Oncology Therapy Development Workshop | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Innovation Mindset – Advancing Science to Therapies | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| FDA Oncology Drug Development Overview – Past to Present | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Federal Resources for Innovative Cancer Startups: More Than Just Funding | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Best Practices for Venture Capital Fundraising: Learn How Early-stage VCs Think | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Funding Sources Panel Discussion | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Building Your Network and Value to Obtain External Input Prior to Interacting with FDA | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Assembling the Best Team to Navigate through Preclinical Development | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Consulting Companies and FDA Limitations Panel Discussion | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| CMC Considerations for CAR T Cell Product Development | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| CMC Considerations for Oncolytic Viral Product Development | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Preclinical Considerations for Cell and Gene Therapy Products, an FDA Perspective | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Oncology Therapy Development Workshop Overview, Day Two | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Chemistry and Manufacturing Requirements for Early Clinical Development: What’s in there? Prove it. | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| CMC Considerations for Biotechnology Product Development: A Regulatory Perspective | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Getting to First-in-Human for Small Molecules and Biologics | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Designing First-In-Human Trials for Small Molecules and Biologics | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Planning for Co-development of Companion Diagnostics | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Clinical Development of Radiopharmaceuticals a Theranostic Pairs and Dosimetry Considerations | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Getting the Best Dose: The Clinical Pharmacology Studies that Help Achieve this Goal | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Oncology Center of Excellence Introduction and Overview of the Oncology Therapy Development Workshop: Panel Discussion | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Drug Master File (DMF) and Drug Substance Workshop | Webinar | 3/3/2021 | Drug Master Files | No |
| Regulatory Perspectives for Development of Drugs for Treatment of NASH | Webinar | 1/29/2021 | New Drug Development; Clinical Trials and Research | No |
| OTC Monograph Reform in the CARES Act: Safety Orders | Webinar | 1/27/2021 | OTC Drug Regulation | No |
| CDER Compliance Conference | Conference/Workshop | 1/14/2021 | Compliance, Import/Export; Compounding; DSCSA; Safety | No |
| Compounding: Cleanrooms and Cleanroom Behaviors: Why they Matter | Conference/Workshop | 1/14/2021 | Compliance, Import/Export; Compounding | No |
| Enhanced Drug Distribution Security – Drug Supply Chain Security Act (DSCSA) Implementation Updates | Conference/Workshop | 1/14/2021 | Compliance, DSCSA | No |
| A Glance at Drug Importation Requirements | Conference/Workshop | 1/14/2021 | Compliance, Import/Export; Compounding | No |
| Risk Evaluation and Mitigation Strategies (REMS) Compliance Program | Conference/Workshop | 1/14/2021 | Compliance, Safety | No |
| Drug Master File (DMF) Submissions on New FDA Form 3938 | Webinar | 1/13/2021 | Drug Master File | No |
| Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA | Webinar | 12/16/2020 | Clinical Trials and Research | No |
| SEND for CBER, What You Need to Know | Webninar | 12/4/2020 | Regulatory Submissions | No |
| Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions | Webinar | 11/20/2020 | Generic Drug Development | No |
| Office of Prescription Drug Promotion - Core Launch Review Process | Webinar | 11/20/2020 | Marketing | No |
| Bridging the Gap – Promoting Safe and Effective Prescription Drug Use in Geriatric Patients | Webinar | 11/13/2020 | Labeling | No |
| Office of New Drug (OND) Research: Seeking Collaborators, Funding Opportunities Available | Webinar | 11/6/2020 | New Drug Development | No |
| Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Opening Remarks and FDA's Orange Book: A Historical Review of 40 Years | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book 101: An Overview of FDA's Orange Book | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| How to Update Orange Book Information | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| How to Update Orange Book Information – Panel Discussion | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| An Overview of FDA's Patent Listing Process | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Changes to Orange Book Patent Information | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book Patent Information – Panel Discussion | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| The Patent Information Dispute Process | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Best Practices for 505(b)(2) and ANDA Applicants | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Patent Dispute and Best Practices for 505(b)(2) and ANDA Applicants – Panel Discussion | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book Exclusivity: An Introduction and Overview | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book Exclusivity: Part I - NCE and 3-Year | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book Exclusivity – Panel Discussion | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book Exclusivity: Part II - Pediatric, Orphan, and GAIN | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book Exclusivity: Part III - 180-Day and Competitive Generic Therapy Exclusivities | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book Exclusivity – Panel Discussion | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book: An Overview of Therapeutic Equivalence | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Referencing Approved Drug Products in ANDA Submissions | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book: Looking Towards the Future | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Closing Remarks | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment | Webinar | 10/15/2020 | Drug Development; Clinical Trials and Research | No |
| Drug Registration and Listing Workshop | Conference/Workshop | 10/8/2020 | Registration and Listing | No |
| Drug Registration and Listing Workshop: Labeler Code Request | Conference/Workshop | 10/8/2020 | Registration and Listing | No |
| Drug Registration and Listing Workshop: Establishment Registration | Conference/Workshop | 10/8/2020 | Registration and Listing | No |
| Drug Registration and Listing Workshop: Drug Listing | Conference/Workshop | 10/8/2020 | Registration and Listing | No |
| Drug Registration and Listing Workshop: 503B Compounder Product Reporting Using CDERDirect | Conference/Workshop | 10/8/2020 | Registration and Listing | No |
| Drug Registration and Listing Workshop: Establishment Registration and Drug Listing Compliance Program | Conference/Workshop | 10/8/2020 | Registration and Listing | No |
| Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs | Webinar | 10/2/2020 | Drug Quality | No |
| Advancing Innovative Science in Generic Drug Development Workshop | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Dr. Hahn's Remarks to “Advancing Innovative Science in Generic Drug Development” Workshop 9/29/2020 | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Update on GDUFA Science and Research | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| March 2020 Transition Under the BPCI Act: Impact on Generics | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Related Impurities Assessment Considerations for APIs in the Generic Complex Peptide Products | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Non-clinical Evaluation of Immunogenicity Risk of Generic Complex Peptide Products | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel Discussion on Method Development / Validations for Non-traditional Analytical Methods | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Developing and Validating Advanced Microscopy Methods for Supporting Complex Product Equivalence | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Developing & Validating Commonly Employed Particle Sizing Methods to Support BE and Product Quality | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Quantitative Methods for Determining Equivalence of Particle Size Distributions | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel for Advanced Analytical and Statistical Methods for Assessing Particle Size Distributions | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Assessment of Complex Drug Product – Physicochemical Characteristics to Support In Vitro BE Studies | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| In Vitro Release Testing for Complex Generics: A Bioequivalence Perspective | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| In Vitro Bioequivalence Studies of Topical Drug Products: Challenges and Promises of IVRT and IVPT | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel on Development and Validation Considerations for Drug Release and Permeation Testing | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Calculating Maximum Daily Dose (MDD) for Orally Administered Drug Products | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| What’s New in the Inactive Ingredient Database (IID)? | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Local Toxicity Considerations for Qualifying Excipients in Generic Drugs | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel on Excipient and Formulation Considerations | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| In Vitro Studies for Alternative BE Approaches to Comparative Clinical Endpoint BE Studies | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| The Potential of PK BE Studies in Detecting Regional Deposition with Orally Inhaled Drugs | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Regional Deposition and Systemic Pharmacokinetic Data of OINDPs with Modeling and Simulation | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel on Future Directions, Emerging Technology, and Current Thinking on Alternative BE Approaches | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Topical Dosage Forms: Emerging Insights and Implications for Bioequivalence Approaches | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| In Vivo Dermal Microperfusion & Microdialysis Bioequivalence Approaches | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Non-Invasive Raman Spectroscopy-Based Bioequivalence Approaches | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel on Topical Dermatologic Products | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| PBPK to Guide Study Design and Product Development for Generic Dermatological Products | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Model-Informed and Model-Integrated Approach in BE Assessment of Long-Acting Injectable Products | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel on Emerging Use of Modeling and Simulation for Bioequivalence | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Biopharmaceutics Classification System Class 3 Waiver | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Using PBPK Absorption Modeling to Support Biopharmaceutics Classification System Class 3 Drug Waiver | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Alternatives to f2 Testing for Dissolution Similarity – f2 Bootstrapping and MSD Method | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel on Practical Considerations in the Study Design and Data Evaluation Recommended in PSGs | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| A Closer Look into the Nasogastric and Gastric Feeding Tube Study Recommendations | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| In Vitro Enteral (Nasogastric and Gastric) Feeding Tube Testing of Generic Drugs: Case Studies | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Practical Considerations for Bioequivalence of GI Locally-Acting Products | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel on In Vitro Feeding Tube Testing and GI Locally-Acting Products | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Cannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations | Webinar | 9/16/2020 | Drug Master Files | No |
| Real-world Evidence for Drugs, Biologics, and Devices - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; Real World Evidence; Postapproval | No |
| Restructure of the Office of New Drugs (OND) - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval | No |
| So, Your NDA Was Approved – Now What?! Post-approval Responsibilities and Obligations- REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval | No |
| Overview of Postmarketing Drug Safety Reporting Requirements - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Safety | No |
| Drug Shortages - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Drug Shortages | No |
| Enhanced Drug Distribution Security – DSCSA Implementation Updates - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; DSCSA | No |
| CDER Export Certificate Program - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Import/Export | No |
| SBIA Program Overview - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Resources | No |
| Post-Approval Submission of Promotional Materials to the OPDP - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Marketing | No |
| Requirement for Electronic Submission of an Application and Study Data - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Regulatory Submissions | No |
| Overview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Drug Quality | No |
| Lifecycle Changes to Chemistry, Manufacture, and Controls in NDAs - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Drug Quality | No |
| Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Drug Quality | No |
| Questions and Panel Discussion – Post-approval CMC and Manufacturing - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Drug Quality | No |
| FDA Drug Manufacturing Inspections - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Inspections | No |
| Bioanalysis of Endogenous Compounds in PK BE Studies in ANDAs - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Bioanalysis of the Dried Blood Spot (DBS) by Mass Spectrometry for Clinical Studies -Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Bioanalysis of Unstable Analytes in Pharmacokinetic BE Studies for ANDAs - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Bioanalytical Method Validation: History, Process, and Regulatory Perspectives - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Case Study: Bioanalytical Approaches to Mitigate Issues during a BE Inspection - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Common Deficiencies for Study Sample Reanalysis in PK BE for ANDAs - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Considerations on ex vivo Conversion of Prodrugs during Bioanalysis - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| CREST Site Selection Model Overview - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Keynote - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Office of Clinical Pharmacology (OCP): Biosimilars - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Office of Clinical Pharmacology (OCP): Drugs and Biologics - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Office of Clinical Pharmacology (OCP): Panel Discussion - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Office of Generic Drugs Panel Discussion - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Office of Study Integrity and Surveillance Session (OSIS) Panel Discussion - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Overview of Immunogenicity Inspections - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Panel Discussion - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Regulated Bioanalysis for Small Molecules - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Regulated Bioanalysis of Large Molecules - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Regulatory Education for Industry: Regulated Bioanalysis Workshop: Requirements and Expectations | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| What Meta-analysis Can Tell You about the Performance of Bioanalytical Methods - Bioanalysis | Conference/Workshop | 6/30/2020 | Generic Drug Development | No |
| Keynote: Pharmaceutical Quality: A Global Priority (CDER) (1/15) Global Quality | Webinar | 7/23/2020 | Drug Quality; International | No |
| An International Commitment to Pharmaceutical Quality (2/15) Global Quality | Webinar | 7/23/2020 | Drug Quality; International | No |
| Manufacturing Assessment and Application Action (3/15) Global Quality | Webinar | 7/23/2020 | Drug Quality; International | No |
| Pre-Approval Inspections and Alternative Approaches to Facility Assessment (4/15) Global Quality | Webinar | 7/23/2020 | Drug Quality; Inspections; International | No |
| An Overview of Pre-License Inspections for Biotech Products (5/15) Global Quality | Webinar | 7/23/2020 | Drug Quality; Inspections; International | No |
| Panel Discussion (6/15) Global Quality | Webinar | 7/23/2020 | Drug Quality; Inspections; International | No |
| FDA’s International Mission and the Global Manufacturing Landscape (7/15) Global Quality | Webinar | 7/23/2020 | Drug Quality; International | No |
| Quality Management Maturity: FDA Vision & Expectations (8/15) Global Quality | Webinar | 7/23/2020 | Drug Quality; International | No |
| Major Issues and Facilities in Drug Master Files (9/15) Global Quality | Webinar | 7/23/2020 | Drug Quality; Drug Master Files; International | No |
| Pharmaceutical Quality Policies: What You Need to Know (10/15) Global Quality | Webinar | 7/23/2020 | Drug Quality; International | No |
| Panel Discussion (11/15) Global Quality | Webinar | 7/23/2020 | Drug Quality; Drug Master Files; International | No |
| FDA’s International Office and the Pharmaceutical Quality Mission (12/15) Global Quality | Webinar | 7/23/2020 | Drug Quality; International | No |
| The State of Pharmaceutical Quality: Surveillance Findings (13/15) Global Quality | Webinar | 7/23/2020 | Drug Quality; International | No |
| Successfully Implementing Advanced Manufacturing (14/15) Global Quality | Webinar | 7/23/2020 | Drug Quality; International | No |
| Panel Discussion (15/15) Global Quality | Webinar | 7/23/2020 | Drug Quality; International | No |
| A Pharmaceutical Quality Webinar for Global Stakeholders | Webinar | 7/23/2020 | Drug Quality; International | No |
| CDER SEND Common Issues and Policy Update | Webinar | 6/15/2020 | Regulatory Submissions | No |
| Best Practices for Proprietary Name Design – Pharmacovigilance | Conference/Workshop | 6/9/2020 | Safety | No |
| Combination Products: Reporting Device Information and Malfunctions - Pharmacovigilance | Conference/Workshop | 6/9/2020 | Safety | No |
| Considerations for REMS Surveys and Assessments: Planning and Reporting - Pharmacovigilance | Conference/Workshop | 6/9/2020 | Safety | No |
| Designing User Interfaces to Prevent Medication Errors – Pharmacovigilance | Conference/Workshop | 6/9/2020 | Safety | No |
| Development of Shared System REMS & Implications of the Appropriations Act - Pharmacovigilance | Conference/Workshop | 6/9/2020 | Safety | No |
| Digital IND Safety Reporting - Pharmacovigilance | Conference/Workshop | 6/9/2020 | Safety; IND | No |
| Division of Risk Management: Overview of Review Activities and REMS - Pharmacovigilance | Conference/Workshop | 6/9/2020 | Safety | No |
| FDA Adverse Event Reporting System (FAERS) Overview - Pharmacovigilance | Conference/Workshop | 6/9/2020 | Safety | No |
| FDA's Sentinel Initiative - Pharmacovigilance | Conference/Workshop | 6/9/2020 | Safety | No |
| ICSR Data Quality of Coding: Products, Adverse Events and Medication Errors - Pharmacovigilance | Conference/Workshop | 6/9/2020 | Safety | No |
| Keynote – Pharmacovigilance and Risk Management Conference | Conference/Workshop | 6/9/2020 | Safety | No |
| Postmarket Safety Surveillance: Tools, Methods, and Benefit-Risk Framework - Pharmacovigilance | Conference/Workshop | 6/9/2020 | Safety | No |
| Preventing Medication Errors: Lessons Learned from Postmarket Safety Surveillance– Pharmacovigilance | Conference/Workshop | 6/9/2020 | Safety | No |
| Process for Reviewing Nonproprietary Name Suffix for Biological Products – Pharmacovigilance | Conference/Workshop | 6/9/2020 | Safety | No |
| Questions and Discussion – Pharmacovigilance | Conference/Workshop | 6/9/2020 | Safety | No |
| REMS Integration Initiatives - Pharmacovigilance | Conference/Workshop | 6/9/2020 | Safety | No |
| Pharmacovigilance and Risk Management Conference – New Approaches, Tools, and Technologies | Conference/Workshop | 6/9/2020 | Drug Development; Drug Safety | No |
| Monograph reform is here! Learn what to expect and how to prepare. | Webinar | 5/29/2020 | Regulatory Submissions; OTC Drug Regulation | No |
| Still submitting paper to CDER? Send electronically with CDER’s NextGen Portal instead! | Webinar | 5/26/2020 | Regulatory Submissions | No |
| Conducting Clinical Trials During the COVID-19 Public Health Emergency | Webinar | 4/30/2020 | New Drug Development | No |
| Postmarketing Drug Safety Compliance: 2019 Inspection Findings | Webinar | 4/29/2020 | Safety; Inspections | No |
| Updates on FDA’s Drug-Drug Interaction Final Guidances | Webinar | 4/24/2020 | New Drug Development; IND | No |
| Generic Drugs Forum - April 15&16, 2020 | Conference/Workshop | 4/15/2020 | Generic Drug Development; Drug Quality | No |
| ANDA Program Performance Review and Tips (8/16) Generic Drugs Forum | Conference/Workshop | 4/15/2020 | Generic Drug Development; Drug Quality | No |
| Application Case Studies on FDA’s Action Letter Timing (16/16) Generic Drugs Forum | Conference/Workshop | 4/15/2020 | Generic Drug Development; Drug Quality | No |
| Common CMC (Quality) Issues and How to Avoid Them Part I (12/16) Generic Drugs Forum | Conference/Workshop | 4/15/2020 | Generic Drug Development; Drug Quality | No |
| Common CMC (Quality) Issues and How to Avoid Them Part II (14/16) Generic Drugs Forum | Conference/Workshop | 4/15/2020 | Generic Drug Development; Drug Quality | No |
| Current Global Generic Drug Landscape (10/16) Generic Drugs Forum | Conference/Workshop | 4/15/2020 | Generic Drug Development; Drug Quality | No |
| Electronic Submission of an ANDA Application and Study Data (7/16) Generic Drugs Forum | Conference/Workshop | 4/15/2020 | Generic Drug Development; Drug Quality | No |
| Facility Readiness: GMPs, Quality Assessments, and Compliance Trends (15/16) Generic Drugs Forum | Conference/Workshop | 4/15/2020 | Generic Drug Development; Drug Quality | No |
| Generic Combination Products: Assessment and Regulatory Update (14/16) Generic Drugs Forum | Conference/Workshop | 4/15/2020 | Generic Drug Development; Drug Quality | No |
| Generic Drug Labeling: Recommendations for High-Quality Submissions (4/28) Generic Drugs Forum | Conference/Workshop | 4/15/2020 | Generic Drug Development; Drug Quality | No |
| ICH Q12 Guidance and Emerging Technology Program (11/16) Generic Drugs Forum | Conference/Workshop | 4/15/2020 | Generic Drug Development; Drug Quality | No |
| Keynote from the Office of Pharmaceutical Quality (OPQ) (2/16) Generic Drugs Forum | Conference/Workshop | 4/15/2020 | Generic Drug Development; Drug Quality | No |
| Keynote: Generic Drug Program Update (1/16) Generic Drugs Forum | Conference/Workshop | 4/15/2020 | Generic Drug Development; Drug Quality | No |
| New Programs and Requirements Under FDARA (5/16) Generic Drugs Forum | Conference/Workshop | 4/15/2020 | Generic Drug Development; Drug Quality | No |
| Pre-ANDA Interactions with the FDA (6/16) Generic Drugs Forum | Conference/Workshop | 4/15/2020 | Generic Drug Development; Drug Quality | No |
| Product Specific Guidances (PSGs) (3/16) Generic Drugs Forum | Conference/Workshop | 4/15/2020 | Generic Drug Development; Drug Quality | No |
| The Importance of Generic Drug Pharmacovigilance (9/16) Generic Drugs Forum | Conference/Workshop | 4/15/2020 | Generic Drug Development; Drug Quality | No |
| Learn About ClinicalTrials.gov Modernization and How to Provide Input | Webinar | 3/6/2020 | Clinical Trials and Research | No |
| Recent Revisions to the ANDA Prioritization MAPP | Webinar | 1/30/2020 | Generic Drug Development | No |
| Improving Regulatory Communication via the CDER NextGen Portal | SBIA Chronicles Podcast | 12/29/2019 | Regulatory Submissions | No |
| Improving Regulatory Communication via the CDER NextGen Portal | SBIA Chronicles | 12/19/2019 | Regulatory Submissions | No |
| 2019 CDER Prescription Drug Labeling Conference - December 4-5, 2019 | Conference/Workshop | 12/4/2019 | New Drug Development; Labeling | No |
| A Recipe for Clinical Pharmacology Information in Labeling (1/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| Adverse Reaction Information in Prescribing Information (3/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| Drug Product Nomenclature (15/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| Improving the Accuracy of SPL Submissions “The Missing LOINC” (9/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| Indications and Usage & Drug Abuse and Dependence Sections of Labeling (2/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| Instructions for Use (IFU) Content and Format Draft Guidance (13/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| Labeling Case Study: Transformation of an Indication (6/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| Labeling Finalization: Final Check of Prescribing Information (8/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| Labeling for Biological Products (11/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| Panel Questions and Discussion (10/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| Panel Questions and Discussion (16/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| Panel Questions and Discussion (19/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| Panel Questions and Discussion (7/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| Pediatric Information In Prescribing Information (4/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| Prescribing Information and Carton/Container Labeling Consistency (18/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| Product Title & Initial US Approval in the Highlights Section (14/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| Safety Considerations for Container Labels and Carton Labeling (17/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| The Pregnancy and Lactation Labeling Rule: Four Years In — What’s next? (5/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| Voluntary PLR Conversions and Updating Prescribing Information (1/19) | Conference/Workshop | 12/4/2019 | Labeling | No |
| 2019 CDER Prescription Drug Labeling Conference | Conference/Workshop | 12/4/2019 | Labeling | No |
| FDA Study Data Technical Conformance Guide v4.4 | Webinar | 11/22/2019 | Regulatory Submissions | No |
| Clinical Investigator Training Course | Conference/Workshop | 11/12/2019 | New Drug Development | No |
| Technical Specifications for Submitting Data for QT Studies | Webinar | 11/8/2019 | Regulatory Submissions | No |
| Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS) | Webinar | 11/1/2019 | Safety; IND; Regulatory Submissions | No |
| OPDP Electronic Submissions – Common Errors in eCTD and How to Avoid Them | Webinar | 10/25/2019 | Regulatory Submissions; Marketing | No |
| Compliance Program and Case Study (7/8) Registration and Listing | Conference/Workshop | 10/22/2019 | Registration and Listing | No |
| Electronic Drug Registration and Listing Using CDER Direct | Conference/Workshop | 10/22/2019 | Registration and Listing | No |
| Establishment Registration and Labeler Code Requests (3/8) Registration and Listing | Conference/Workshop | 10/22/2019 | Registration and Listing | No |
| Keynote from the Drug Registration and Listing Staff (2/8) Registration and Listing | Conference/Workshop | 10/22/2019 | Registration and Listing | No |
| Listing Certification and Inactivation (6/8) Registration and Listing | Conference/Workshop | 10/22/2019 | Registration and Listing | No |
| NDC Reservation, Listing, 503B Compounded Product (5/8) Registration and Listing | Conference/Workshop | 10/22/2019 | Registration and Listing | No |
| Panel Questions and Discussion (4/8) Drug Registration and Listing Using CDER Direct | Conference/Workshop | 10/22/2019 | Registration and Listing | No |
| Panel Questions and Discussion (8/8) Registration and Listing | Conference/Workshop | 10/22/2019 | Registration and Listing | No |
| Welcome from CDER’s Office of Compliance (1/8) Registration and Listing | Conference/Workshop | 10/22/2019 | Registration and Listing | No |
| Application Manufacturing Assessment (4/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Assessment of the Multi-Attribute Method (MAM) Substance (23/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Biosimilars and Interchangeables - Regulatory Highlights (27/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Case Studies: Continuous Manufacturing of Drug Substance (21/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Change Management: ICH Q12 and Established Conditions (12/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Continuous Manufacturing of Drug Product (20/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Data Quality Expectations for Biosimilars with Case Studies (29/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Emerging Technology Program (18/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| End-to-end Integrated Continuous Manufacturing (25/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| FDA Perspectives on Biosimilar BLA-Manufacturing (28/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| FDA Research Supporting Emerging Technologies with Case Studies (24/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| FDA’s Quality Assessment and Knowledge Management - KASA (11/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| How Does FDA Execute Pre- and Post-approval Inspections? (7/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Integration of Assessment and Inspection for Biological Products (9/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Keynote: CDER’s Commitment to Pharmaceutical Quality (1/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Panel Questions and Discussion (10/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Panel Questions and Discussion (13/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Panel Questions and Discussion (17/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Panel Questions and Discussion (22/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Panel Questions and Discussion (26/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Panel Questions and Discussion (30/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Panel Questions and Discussion (33/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Panel Questions and Discussion (6/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Pharmaceutical Quality Surveillance Program (14/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Pharmaceutical Quality Symposium | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Policy Considerations for Continuous Manufacturing (19/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Policy Initiatives for Pharmaceutical Quality (5/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Quality Assessment of BLAs, NDAs, and ANDAs (3/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Quality Considerations for Transition Biological Products (32/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Quality Metrics, Quality Culture, and Data-Driven Decisions (16/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Quality-Related Compliance Actions and Trends (15/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Small Molecule Case Studies (8/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| The “Deemed to be a License” Provision of the BPCI Act (31/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality; Biosimilars; BLA; NDA | No |
| The Importance of Quality in Our Medicines (2/33) Quality | Conference/Workshop | 10/16/2019 | Drug Quality | No |
| Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards | Webinar | 10/11/2019 | Regulatory Submissions; Safety | No |
| 2019 Complex Generic Drug Product Development Workshop | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| BE Approaches for Long Acting Drug Products (14/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| BE for Bridging Studies with Orally Inhaled/Nasal Drugs (26/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Bioequivalence for Generic Topical and Transdermal (6/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| CMC Updates for Orally Inhaled Drugs (27/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Comparative Analyses: Device and User Interface (25/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Comparative Analyses: Injectable Combination Products (21/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Complex Peptide ANDAs: Test/Reference Comparability (11/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Considerations of Particle Analysis (12/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| CREdIbility for Computational Fluid Dynamics Models (33/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Dose-Scale Analysis in Pharmacodynamic Equivalence (31/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| FDA’s Inactive IngREdIent Database (IID) (3/f35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Generic Topical and Transdermal Products (5/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| In Vitro Drug Release Testing for LA Drug Products QC (16/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Keynote with Sally Choe (1/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Overview of Comparative Analyses - Clinical Perspective (19/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Panel Questions and Discussion (35/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Physiologically-based Pharmacokinetic Modeling (32/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| PK/PD Meta-analysis of Abuse Deterrent Opioid Drugs (30/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Pre-ANDA Meeting Requests for Orally Inhaled/Nasal Drugs(24/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Pre-ANDA Program Update (2/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| PSG Recommendations and Updates for OINDPs (23/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Quality for Transdermal Delivery Systems (8/35) Complex Generic Drugs | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Quality View on Injectable Product Considerations (20/35) Complex Generic Drugs | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Quantitative Clinical Pharmacology in LA Injectables (34/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Quantitative Methods and Modeling (29/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Questions and Answers (13/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Questions and Answers (17/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Questions and Answers (22/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Questions and Answers (28/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Questions and Answers (4/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Questions and Answers (9/35) Complex Generic Drugs | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Strategies for Generic Topical Product Development (7/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Strategies to Demonstrate Complex API Sameness (10/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| Strategies to Demonstrate Complex Excipient Sameness (15/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| What Constitutes Complex Drug-Device Combination (18/35) Complex Generics | Conference/Workshop | 9/25/2019 | Generic Drug Development; Drug Quality | No |
| REdI and CERSI Workshop: Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls | Conference/Workshop | 9/23/2019 | New Drug Development | No |
| Abbreviated Approval Pathways - 505(b)(2) or ANDA? | SBIA Chronicles | 9/19/2019 | Generic Drug Development; NDA | No |
| Abbreviated Approval Pathways - 505(b)(2) or ANDA? | SBIA Chronicles Podcast | 9/19/2019 | Generic Drug Development; NDA | No |
| Most Common Issues with CDISC-SEND Data in FDA Toxicology Review | Webinar | 9/12/2019 | Regulatory Submissions | No |
| eCTD Submissions of Promotional Labeling and Advertising Materials | Webinar | 8/12/2019 | Regulatory Submissions; Marketing | No |
| Risk-Based Approach to Monitoring Clinical Investigations: Overview of FDA Draft Guidance Issued for Comment | Webinar | 6/26/2019 | Clinical Trials and Research | No |
| Research Investigational New Drug Applications – What You Need To Know | SBIA Chronicles | 6/25/2019 | Clinical Trials and Research; IND | No |
| Research Investigational New Drug Applications – What You Need To Know | SBIA Chronicles Podcast | 6/25/2019 | Clinical Trials and Research; IND | No |
| Bioanalytical Method Validation of ANDAs – What the Assessor Looks for During Inspections | Webinar | 6/17/2019 | Generic Drug Development | No |
| Accuracy and Precision in Bioanalysis: Review of Case Studies | Webinar | 6/17/2019 | New Drug Development | No |
| Bioanalytical Method Validation (BMV) Panel Discussion | Webinar | 6/17/2019 | New Drug Development | No |
| Bioanalytical Inspections: Overview and Case Studies | Webinar | 6/17/2019 | New Drug Development | No |
| How should I measure this? An FDA perspective on the Bioanalytical Method Validation (BMV) | Webinar | 6/17/2019 | New Drug Development | No |
| The Finalized Bioanalytical Method Validation Guidance: What’s New For NDAs and BLAs | Webinar | 6/17/2019 | New Drug Development; NDA; BLA | No |
| Identification of Medicinal Products (IDMP): What is IDMP and Why Should I Care? | Webinar | 6/13/2019 | New Drug Development | No |
| CDER FDA Exclusivity – Which One Is for Me? | Webinar | 6/10/2019 | User Fees; NDA; BLA | No |
| FDA Orphan Drugs Program and Financial Incentives for CDER Medical Products | Webinar | 6/10/2019 | User Fees; NDA; BLA | No |
| Financial Incentives for CDER Medical Products | Webinar | 6/10/2019 | User Fees; NDA; BLA | No |
| Navigating the World of Biosimilar User Fees | Webinar | 6/10/2019 | BLA; User Fees | No |
| Panel on Financial Incentives for CDER Medical Products - PDUFA & Biosimilars | Webinar | 6/10/2019 | User Fees; NDA; BLA | No |
| Prescription Drug User Fee Act Waivers, Exemptions, and Refunds -Oh My | Webinar | 6/10/2019 | User Fees; NDA; BLA | No |
| A Medical Officer’s Approach to NDA/BLA Review (8/15) REdI Annual Conference | Conference/Workshop | 5/29/2019 | New Drug Development; IND; Resources | No |
| CDER Industry Assistance Resources (1/15) REdI | Conference/Workshop | 5/29/2019 | New Drug Development; IND; Resources | No |
| CDER’s Review of the Prescribing Information (11/15) REdI– May 29-30, 2019 | Conference/Workshop | 5/29/2019 | New Drug Development; IND | No |
| CMC - NDA requirements and Common Pitfalls of BLAs (14/15) REdI | Conference/Workshop | 5/29/2019 | New Drug Development; IND | No |
| Components of New Drug Application and Biologics License Application (5/15) REdI | Conference/Workshop | 5/29/2019 | New Drug Development; IND | No |
| Electronic Common Technical Document (eCTD) and Study Data (7/15) REdI | Conference/Workshop | 5/29/2019 | New Drug Development; IND | No |
| Meetings: Pre-submission and Special Programs (4/15) REdI Annual Conference | Conference/Workshop | 5/29/2019 | New Drug Development; IND | No |
| Navigating the World of Combination Products (2/15) REdI | Conference/Workshop | 5/29/2019 | New Drug Development; IND | No |
| NDA and BLA Application Review Process (6/15) REdI Annual Conference | Conference/Workshop | 5/29/2019 | New Drug Development; IND | No |
| Nonproprietary Name Suffix and Safety for Product Design and Labels (10/15) REdI | Conference/Workshop | 5/29/2019 | New Drug Development; IND | No |
| ORA Aligned for the Future (1/15) REdI | Conference/Workshop | 5/29/2019 | New Drug Development; IND | No |
| Pre-Approval Inspections: What to Expect When Being Inspected (15/15) REdI | Conference/Workshop | 5/29/2019 | New Drug Development; IND; Inspections | No |
| Ready to Launch: Essentials of Submitting Initial Materials to OPDP (12/15) REdI | Conference/Workshop | 5/29/2019 | New Drug Development; IND; Marketing | No |
| Regulatory Education for Industry (REdI) Annual Conference - Focus on Essentials of NDAs and BLAs | Conference/Workshop | 5/29/2019 | User Fees; NDA; BLA | No |
| Regulatory Highlights for Biosimilars and Interchangeables (9/15) REdI | Conference/Workshop | 5/29/2019 | New Drug Development; IND | No |
| What can CDER do for you? (3/15) REdI Annual Conference | Conference/Workshop | 5/29/2019 | New Drug Development; IND | No |
| Competitive Generic Therapies | SBIA Chronicles | 5/23/2019 | Generic Drug Development | No |
| Competitive Generic Therapies | SBIA Chronicles Podcast | 5/23/2019 | Generic Drug Development | No |
| An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies | Webinar | 5/9/2019 | Clinical Trials and Research | No |
| Deploying the MyStudies System in a Compliant Manner (8/9) MyStudies App | Webinar | 5/9/2019 | New Drug Development; Real World Evidence | No |
| Final Question and Answer Panel (9/9) MyStudies App | Webinar | 5/9/2019 | New Drug Development; Real World Evidence | No |
| Introduction (1/9) FDA MyStudies Mobile App System | Webinar | 5/9/2019 | New Drug Development; Real World Evidence | No |
| Mobile Application and WCP: Usability and Technical Overview (5/9) FDA MyStudies App | Webinar | 5/9/2019 | New Drug Development; Real World Evidence | No |
| Patient and Researcher Experiences: A Demonstration (2/9) FDA MyStudies App | Webinar | 5/9/2019 | New Drug Development; Real World Evidence | No |
| Patient and Researcher Experiences: Demo of the FDA MyStudies Mobile App (3/9) | Webinar | 5/9/2019 | New Drug Development; Real World Evidence | No |
| Question and Answer Panel (7/9) MyStudies App | Webinar | 5/9/2019 | New Drug Development; Real World Evidence | No |
| Question and Answer Session Martin and Wyner (4/9) FDA MyStudies App | Webinar | 5/9/2019 | New Drug Development; Real World Evidence | No |
| Response Server Technical Overview (6/9) FDA MyStudies App | Webinar | 5/9/2019 | New Drug Development; Real World Evidence | No |
| 505(b)(2) NDA or ANDA? (10/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Assessment Tips (17/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Case Studies: Inadequate Bioequivalence Studies (18/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Complex Product Development (3/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Continuous Manufacturing with a Generic Perspective (25/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Decrease RTR, IR, and CR Due to Dissolution Deficiencies (21/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Deficiencies and Observations from Facility Evaluations and Inspections(27/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Drug Master Files (DMFs) from an ANDA Perspective (7/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Filing and Refuse to Receive (RTR) (16/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Generic Drug Forum: April 3-4, 2019 | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Impurity Case Studies: Pharmacology/Toxicology (22/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Keynote: Generic Drug Program Update (1/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Manufacturing Process and Controls: Avoiding Assessment Issues (26/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Mid-cycle Assessment and Post-complete Response Letter Meetings (6/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Orange Book - Its Role in ANDAs (8/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Practical Tips on eCTD (13/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Pre-ANDA Meeting or Controlled Correspondence? (4/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Questions and Answers (11/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Questions and Answers (15/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Questions and Answers (19/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Questions and Answers (23/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Questions and Answers (28/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Questions and Answers (5/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Referencing Approved Drug Products in ANDA Submissions (9/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Stability Case Studies (20/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| The Importance of Quality in Our Medicines (2/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Tips on Using the CDER NextGen Collaboration Portal (12/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Types of Fees and Q&A (24/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| Update on Technical Rejection Criteria for Study Data (14/28) Generic Drug Forum | Conference/Workshop | 4/3/2019 | Generic Drug Development; Drug Quality | No |
| A New Era for Homeopathic Drug Product Regulation | SBIA Chronicles Podcast | 3/22/2019 | New Drug Development | No |
| Framework for FDA’s Real-World Evidence Program | Webinar | 3/15/2019 | New Drug Development; Real World Evidence | No |
Human Drug Establishment Registration and Drug Listing Compliance; CDERLearn Course
Certificates of completion and embedded videos are no longer available. | CDERLearn Course | 3/12/2019 | Registration and Listing | No |
| FDA Modernizes Clinical Trials with Master Protocols | SBIA Chronicles | 2/26/2019 | New Drug Development; IND; Clinical Trials and Research | No |
| FDA Modernizes Clinical Trials with Master Protocols | SBIA Chronicles Podcast | 2/26/2019 | New Drug Development; IND; Clinical Trials and Research | No |
| Final Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations | Webinar | 12/6/2018 | Clinical Trials and Research; Regulatory Submissions | No |
| Early Engagement with FDA to Discuss Novel Surrogate Endpoints | SBIA Chronicles | 11/27/2018 | New Drug Development; FDA Meetings/Communications | No |
| Early Engagement with FDA to Discuss Novel Surrogate Endpoints | SBIA Chronicles Podcast | 11/27/2018 | New Drug Development; FDA Meetings/Communications | No |
| FDA Study Data Technical Conformance Guide | Webinar | 11/27/2018 | Regulatory Submissions | No |
| Clinical Investigator Training Course (CITC) 2018: November 13 - 15, 2018 | Conference/Workshop | 11/13/2018 | New Drug Development; Clinical Trials | No |
| FDA Facilitates the Use of Surrogate Endpoints in Drug Development | SBIA Chronicles | 11/5/2018 | Clinical Trials and Research; IND | No |
| FDA Facilitates the Use of Surrogate Endpoints in Drug Development | SBIA Chronicles Podcast | 11/5/2018 | Clinical Trials and Research; IND | No |
| A Case Example of the Review of Audit Trails in GCP Inspections (11/11) GCP Data Integrity Workshop | Conference/Workshop | 10/23/2018 | Clinical Trials and Research | No |
| Blinding of Bioequivalence Trials (9/11) GCP Data Integrity | Conference/Workshop | 10/23/2018 | Clinical Trials and Research | No |
| Data Integrity from International Perspectives (2/11) GCP Data Integrity Workshop | Conference/Workshop | 10/23/2018 | Clinical Trials and Research | No |
| Data Quality: Why Do We Care? (1/11) GCP Data Integrity | Conference/Workshop | 10/23/2018 | Clinical Trials and Research | No |
| Effective Use of Audit Trails (10/11) GCP Data Integrity Workshop | Conference/Workshop | 10/23/2018 | Clinical Trials and Research | No |
| FDA & MHRA Good Clinical Practice Workshop: Data Integrity in Global Clinical Trials - Are We There Yet?: October 23-24, 2018 | Conference/Workshop | 10/23/2018 | New Drug Development; Clinical Trials and Research | No |
| Good Clinical Practice Assessment of Data Reliability in Registration Trials (5/11) GCP Data | Conference/Workshop | 10/23/2018 | Clinical Trials and Research | No |
| Overview of Data Integrity (4/11) GCP Data Integrity Workshop | Conference/Workshop | 10/23/2018 | Clinical Trials and Research | No |
| Quality and Control of Clinical Trial Data (6/11) GCP Data Integrity Workshop | Conference/Workshop | 10/23/2018 | Clinical Trials and Research | No |
| Quality Management Systems and Quality By Design (3/11) GCP Data Integrity Workshop | Conference/Workshop | 10/23/2018 | Clinical Trials and Research | No |
| The Data Management Plan – Pulling It All Together (7/11) GCP Data Integrity Workshop | Conference/Workshop | 10/23/2018 | Clinical Trials and Research | No |
| Unblinding – Let Me Count the Ways… (8/11) GCP Data Integrity | Conference/Workshop | 10/23/2018 | Clinical Trials and Research | No |
| Electronic Drug Registration and Listing Using CDER Direct: October 2, 2018 | Conference/Workshop | 10/2/2018 | Registration and Listing | No |
| Writing the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance | Webinar | 9/27/2018 | Labeling | No |
| Real-Time Review of Drug Applications is Now a Reality | SBIA Chronicles | 9/20/2018 | IND; NDA | No |
| Real-Time Review of Drug Applications is Now a Reality | SBIA Chronicles Podcast | 9/20/2018 | IND; NDA | No |
| Complex Generic Drug Product Development Workshop | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Common Issues in Complex Drug Substance Review (8of39) Complex Generics 2018 | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Considerations for Establishing Q1/Q2 Sameness of Complex Formulations (10/39) Complex Generics '18 | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Considerations in Demonstrating Complex API Sameness (7/39) Complex Generics 2018 | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Equivalence testing of complex particle size distribution profiles-earth mover’s distance (15/39) | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Establishing Appropriate BE Limits for Complex Formulations (14/39) Complex Generics 2018 | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| In vitro bioequivalence testing for topical ophthalmic suspension products (17/39) Complex Generics | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| In Vitro Release Testing of Complex Formulations (11/39) Complex Generics 2018 | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Iron Colloid Drug Products: Characterization and Impurity (13/39) Complex Generics 2018 | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Multivesicular Liposomes: Physicochemical characterization & in vitro drug release testing (12/39) | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Office of Generic Drugs Keynote (1/39) Complex Generics 2018 | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| PBPK modeling and simulation used in assessing BE for generic ophthalmic products (19/39) | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Peptide Drug Challenges through Pre-ANDA Processes & Case Studies (6/39) Complex Generics 2018 | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Pre-ANDA Logistics and Best Practices (3/39) Complex Generics 2018 | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Pre-ANDA Program Overview (2/39) Complex Generics 2018 | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Pre-ANDA review: Office of Pharmaceutical Quality (OPQ) (4/39) Complex Generics 2018 | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Product Quality Testing for Topical Ophthalmic Suspension Products (18/39) Complex Generics 2018 | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Questions and Panel Discussion (16/39) Complex Generics 2018 | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Questions and Panel Discussion (20/39) Complex Generics 2018 | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Questions and Panel Discussion (5/39) Complex Generics 2018 | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Questions and Panel Discussion (9/39) Complex Generics 2018 | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| Complex Generic Drug Product Development Workshop - September 12-13, 2018 | Conference/Workshop | 9/12/2018 | Generic Drug Development; Drug Quality | No |
| The FAERS Public Dashboard and its Value to the Pharmaceutical Industry | SBIA Chronicles | 7/10/2018 | Safety | No |
| The FAERS Public Dashboard and its Value to the Pharmaceutical Industry | SBIA Chronicles Podcast | 7/10/2018 | Safety | No |
| Postmarketing Drug Safety and Inspection Readiness - June 19, 2018 Deeper Dive Webinar | Webinar | 6/19/2018 | Inspections; Safety; Postapproval | No |
| BIMO, REMS, and PADE Inspection Readiness (3/3) | Webinar | 6/19/2018 | Safety; Inspections; Postapproval | No |
| Postmarketing Adverse Drug Experience (PADE) Inspections – (1/3) | Webinar | 6/19/2018 | Safety; Inspections; Postapproval | No |
| Risk Evaluation and Mitigation Strategies (REMS) Inspections (2/3) | Webinar | 6/19/2018 | Safety; Inspections; Postapproval | No |
| Benefit-Risk Considerations During Drug Product Development (8/14) REdI 2018 | Conference/Workshop | 5/18/2018 | Drug Development; IND; NDA | No |
| CDER Small Business and Industry Assistance Overview (12/14) REdI 2018 | Conference/Workshop | 5/18/2018 | Drug Development; IND; NDA; Resources | No |
| Chemistry, Manufacturing, and Controls (CMC) for an IND (7/14) REdI 2018 | Conference/Workshop | 5/18/2018 | Drug Development; IND; NDA | No |
| Demystifying the Investigational New Drug (IND) Application for Drugs and Biologics (3/14) REdI 2018 | Conference/Workshop | 5/18/2018 | Drug Development; IND; NDA | No |
| FDA Regulatory Requirements for Clinical Investigators and Case Examples (9/14) REdI 2018 | Conference/Workshop | 5/18/2018 | Drug Development; IND; NDA | No |
| Formal Meetings for PDUFA Products and Communication Best Practices (4/14) REdI 2018 | Conference/Workshop | 5/18/2018 | Drug Development; IND; NDA | No |
| Good Manufacturing Practices (GMPs) from an IND Perspective (11/14) REdI 2018 | Conference/Workshop | 5/18/2018 | Drug Development; IND; NDA | No |
| Human Factors Engineering in Medical Products Reviews (2/14) REdI 2018 | Conference/Workshop | 5/18/2018 | Drug Development; IND; NDA | No |
| Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5/14) REdI 2018 | Conference/Workshop | 5/18/2018 | Drug Development; IND; NDA | No |
| Investigational New Drug Safety Reporting Requirements (10/14) REdI 2018 | Conference/Workshop | 5/18/2018 | Drug Development; IND; NDA | No |
| Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6/14) REdI 2018 | Conference/Workshop | 5/18/2018 | Drug Development; IND; NDA | No |
| Office of Regulatory Affairs Update (1/14) REdI 2018 | Conference/Workshop | 5/18/2018 | Drug Development; IND; NDA | No |
| Panel Discussion (27/27) Generic Drugs Forum April 11-12, 2018 | Conference/Workshop | 5/18/2018 | Drug Development; IND; NDA | No |
| The Active IND and Available Development Programs (13/14) REdI 2018 | Conference/Workshop | 5/18/2018 | Drug Development; IND; NDA | No |
| Walkthrough of a Pre-Approval Manufacturing Site Inspection (14/14) REdI 2018 | Conference/Workshop | 5/18/2018 | Drug Development; IND; NDA | No |
| Regulatory Education for Industry (REdI) Spring Conference: May 15-16, 2018 | Conference/Workshop | 5/15/2018 | New Drug Development; IND | No |
| Optimizing Your Data Submissions to FDA: Office of Vaccines Research and Review (OVRR) Data Submission | Webinar | 5/8/2018 | Regulatory Submissions | No |
| Updates to Forms 356h & 1571: Commercial vs. Research Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) Combination Products | Webinar | 5/4/2018 | Regulatory Submissions | No |
| ANDA Performance/Operations Update (3/27) Generic Drugs Forum April 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Application Communications: RBPM Communication with Industry throughout the IQA (24/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Best Practices for Conducting Bioequivalence Studies (16/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Bioequivalence Site and Manufacturing Facility Information in Applications (17/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Challenges in Generic Drug Safety and Surveillance (6/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Determining Whether to Submit an ANDA or a 505(b)(2) Application (12/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Drug Substance Quality Assessment: Best Practices (23/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Electronic Submissions (7/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Regulatory Submissions | No |
| Filing Review Basics – Examples of Refuse-to-Receive (RTR) (15/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| GDUFA II – Review Timelines (14/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| GDUFA II Pre-ANDA Program Meetings: Advice for Success (10/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality; FDA Meetings/Communications | No |
| GDUFA II User Fees: Update on Year One (21/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Generic Drug Product Quality Assessment (22/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Generic Drugs Forum: April 11 -12, 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development | No |
| Good ANDA Submission and Assessment Practices and Software Support (5/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Integrated Process and Facilities Assessment (26/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Integrated Quality Assessment Process (19/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Keynote Address by Dr. Uhl (1/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Laboratory Science to Support Risk-Based Quality Assessments (25/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Microbiology Quality Assessment (18/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Office of Pharmaceutical Quality (OPQ) Policy Update (4/27) Generic Drugs Forum April 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Orange Book: 101 An Overview (11/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Panel Discussion (13/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Panel Discussion (20/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Panel Discussion (9/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Pharmaceutical Quality Update by Dr. Michael Kopcha (2/27) Generic Drugs Forum April 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| Using the ePortal to Submit a pre-ANDA Meeting (8/27) Generic Drugs Forum 2018 | Conference/Workshop | 4/11/2018 | Generic Drug Development; Drug Quality | No |
| A New Era for Homeopathic Drug Product Regulation | SBIA Chronicles | 3/22/2018 | New Drug Development | No |
| A New Era for Homeopathic Drug Product Regulation | SBIA Chronicles Podcast | 3/22/2018 | New Drug Development | No |
| FDA Helping the Generic Industry Submit Complete Applications | SBIA Chronicles | 2/6/2018 | Generic Drug Development; Regulatory Submissions | No |
| FDA Helping the Generic Industry Submit Complete Applications | SBIA Chronicles Podcast | 2/6/2018 | Generic Drug Development; Regulatory Submissions | No |
| Draft guidance for Industry: Information Requests and Discipline Review Letters Under GDUFA | Webinar | 12/18/2017 | Generic Drug Development; Regulatory Submissions | No |
| REMS Integration Initiative: An Overview | Webinar | 12/4/2017 | Safety | No |
| PDUFA VI - A Time for Change | SBIA Chronicles | 11/28/2017 | User Fees; NDA | No |
| PDUFA VI - A Time for Change | SBIA Chronicles Podcast | 11/28/2017 | User Fees; NDA | No |
| Optimizing Your Study Data Submissions to FDA –Study Data Technical Conformance Guide October 2017 Version Update | Webinar | 11/8/2017 | Regulatory Submissions | No |
| Prescription Drug Labeling Conference 2017 | Conference/Workshop | 11/2/2017 | Labeling | No |
| Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development | Webinar | 11/2/2017 | Generic Drug Development | No |
| PLR Implementation, CDER Staff for Labeling Review, and Resources (1/9) Prescription Drug Labeling 2017 | Conference/Workshop | 11/2/2017 | Labeling | No |
| Consistency, Optimizing Communication, and Best Labeling Practices (2/9) Prescription Drug Labeling 2017 | Conference/Workshop | 11/2/2017 | Labeling | No |
| Considerations for Developing the Indications and Usage Section of Labeling (3/9) Labeling 2017 | Conference/Workshop | 11/2/2017 | Labeling | No |
| Converting Labeling for Older Drugs from the Old Format to the PLR Format (4/9) Prescription Drug Labeling 2017 | Conference/Workshop | 11/2/2017 | Labeling | No |
| Novel and Adaptive Labeling Approaches: PLR and Beyond (5/9) Labeling 2017 | Conference/Workshop | 11/2/2017 | Labeling | No |
| Cracking the Code for Clinical Pharmacology-Related Prescription Drug Labeling (6/9) Prescription Drug Labeling 2017 | Conference/Workshop | 11/2/2017 | Labeling | No |
| Overview of SPL and Challenges with Medication Guide Extraction and Data Mining (7/9)Prescription Drug Labeling 2017 | Conference/Workshop | 11/2/2017 | Labeling | No |
| Lessons Learned with the Pregnancy and Lactation Labeling Rule (PLLR) (8/9) Prescription Drug Labeling 2017 | Conference/Workshop | 11/2/2017 | Labeling | No |
| Safety Considerations for Patient Instructions to Minimize Medication Errors (9/9) Labeling 2017 | Conference/Workshop | 11/2/2017 | Labeling | No |
| Draft Guidance for Industry: Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA | Webinar | 11/1/2017 | Generic Drug Development; FDA Meetings/Communications | No |
| Draft Guidance for Industry: Determining Whether to Submit an ANDA or 505(b)(2) Application | Webinar | 10/13/2017 | Generic Drug Development; NDA | No |
| Electronic Drug Registration & Listing Using CDER Direct: Extended Webinar | Webinar | 10/5/2017 | Registration and Listing | No |
| Draft Guidance for Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA | Webinar | 10/2/2017 | Generic Drug Development; FDA Meetings/Communications | No |
| Regulatory Education for Industry (REdI): Fall Conference: September 27-28, 2017 | Conference/Workshop | 9/27/2017 | New Drug Development; IND | No |
| Keynote (1/14) REdI 2017 | Conference/Workshop | 9/27/2017 | New Drug Development; IND | No |
| Plenary: Regulatory Research at FDA (2/14) REdI 2017 | Conference/Workshop | 9/27/2017 | New Drug Development; IND | No |
| Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017 | Conference/Workshop | 9/27/2017 | New Drug Development; IND | No |
| FDA Communication During Drug Development (4/14) REdI 2017 | Conference/Workshop | 9/27/2017 | New Drug Development; IND; FDA Meetings/Communications | No |
| Regulatory and Administrative Components of an IND Application (5/14) REdI 2017 | Conference/Workshop | 9/27/2017 | New Drug Development; IND; Regulatory Submissions | No |
| Benefit-Risk Considerations in Drug Development (6/14) REdI 2017 | Conference/Workshop | 9/27/2017 | New Drug Development; IND | No |
| Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) (7/14) REdI 2017 | Conference/Workshop | 9/27/2017 | New Drug Development; IND; Drug Quality | No |
| Overview of Non-clinical Assessment in Drug Development (8/14) REdI 2017 | Conference/Workshop | 9/27/2017 | New Drug Development; IND | No |
| Submit Your Investigational New Drug (IND) Application and Clinical Holds (9/14) REdI 2017 | Conference/Workshop | 9/27/2017 | New Drug Development; IND; Regulatory Submissions | No |
| Additional Sponsor Responsibilities (10/14) REdI 2017 | Conference/Workshop | 9/27/2017 | New Drug Development; IND | No |
| Overview of Clinical Investigator Responsibilities and Inspectional Findings (11/14) REdI 2017 | Conference/Workshop | 9/27/2017 | New Drug Development; IND | No |
| Walkthrough of an FDA Clinical Investigator Site Inspection (12/14) REdI 2017 | Conference/Workshop | 9/27/2017 | New Drug Development; IND; Inspections | No |
| Overview of FDA's Expanded Access Program (13/14) REdI 2017 | Conference/Workshop | 9/27/2017 | New Drug Development; IND | No |
| Live Demo of the FDA Adverse Events Reporting System (14/14) REdI 2017 | Conference/Workshop | 9/27/2017 | New Drug Development; IND; Drug Safety | No |
| Real-World Data and Evidence in Drug Development | SBIA Chronicles | 8/24/2017 | New Drug Development | No |
Electronic Common Technical Document (eCTD): CDERLearn Course
Certificates of completion and embedded videos are no longer available. | CDERLearn Course | 8/3/2017 | Regulatory Submissions | No |
| Optimizing Your Study Data Submissions to FDA – Updates from CDER and CBER | Webinar | 7/13/2017 | Regulatory Submissions | No |
| Updates to the Study Data Technical Conformance Guide (1/4) Technical Conformance | Webinar | 7/13/2017 | Regulatory Submissions | No |
| Providing Clinical Study Data to the Office of Vaccines (2/4) Tech Conformance | Webinar | 7/13/2017 | Regulatory Submissions | No |
| Biologics Quality Bioresearch and Study Data Submissions (3/4) Technical Conformance | Webinar | 7/13/2017 | Regulatory Submissions | No |
| Panel Questions and Discussion (4/4) Study Data Technical Conformance Webinar | Webinar | 7/13/2017 | Regulatory Submissions | No |
| Draft Guidance for Industry: ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA II II | Webinar | 7/5/2017 | Generic Drug Development; Regulatory Submissions | No |
| Presenting Clinical Pharmacology Information in Prescription Drug Labeling | Webinar | 6/19/2017 | Labeling | No |
| Risk Evaluation and Mitigation Strategies (REMS): A Deeper Dive | Webinar | 6/15/2017 | New Drug Development; Safety | No |
| REMS Purpose, Process, and Challenges (1/2) REMS Webinar | Webinar | 6/15/2017 | New Drug Development; Safety | No |
| Structured Product Labeling Format: An Introduction (2/2) REMS Webinar | Webinar | 6/15/2017 | New Drug Development; Safety; Regulatory Submissions | No |
| Submitting Master Files in eCTD Format: When and How to Comply | SBIA Chronicles | 5/25/2017 | Drug Master Files; Regulatory Submissions | No |
| Submitting Master Files in eCTD Format: When and How to Comply | SBIA Chronicles Podcast | 5/25/2017 | Drug Master Files; Regulatory Submissions | No |
| Regulatory Education for Industry (REdI): Spring Conference: May 9-10, 2017 | Conference/Workshop | 5/9/2017 | New Drug Development; IND | No |
| The Complexities of Compounding | SBIA Chronicles | 4/20/2017 | Compounding | No |
| The Complexities of Compounding | SBIA Chronicles Podcast | 4/20/2017 | Compounding | No |
| Generic Drugs Forum: April 4-5, 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development | No |
| Keynote – Office of Generic Drugs (1/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development | No |
| Keynote – Office of Pharmaceutical Quality (2/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development; Drug Quality | No |
| ANDA Performance/Operations Update (3/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development | No |
| Office of Pharmaceutical Quality Policy Update (4/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development; Drug Quality | No |
| GDUFA Regulatory Science Research Update (5/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development | No |
| Preparing for GDUFA II User Fees (6/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development | No |
| eCTD (7/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development; Regulatory Submissions | No |
| Panel Discussion (8/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development; Regulatory Submissions; Drug Quality | No |
| GDUFA II (9/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development; User Fees | No |
| Development of Single, Shared System REMS (10/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development; Drug Safety | No |
| Introduction to “The ANDA Review Pathway” (11/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development | No |
| ANDA Policy and Regulatory Considerations Prior to Filing (12/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development | No |
| Panel Discussion (13/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development | No |
| Filing Review – Do’s and Don’ts (14/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development; Regulatory Submissions | No |
| RPM Communications Associated with “Take Action” Process (15/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development | No |
| FDA’s Bioequivalence Recommendations for Generic Drugs (16/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development | No |
| Review of Clinical Endpoint Bioequivalence Studies in ANDAs (17/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development | No |
| Generic Labeling: Strategies for Providing High-quality Submissions (18/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development; Labeling | No |
| Panel Discussion (19/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development | No |
| OPQ Integrated Quality Assessment (IQA) Process (20/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development; Drug Quality | No |
| OPQ Communications with Industry (21/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development; Drug Quality | No |
| Drug Substance Review - ANDA (22/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development; Drug Quality | No |
| Generic Drug Product Quality Review (23/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development; Drug Quality | No |
| Dissolution Method Development for Generic Drugs (24/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development; Drug Quality | No |
| Manufacturing Process and Controls (25/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development; Drug Quality | No |
| Facility Evaluation and Inspection (26/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development; Drug Quality; Inspections | No |
| Product Quality Microbiology Assessment (27/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development; Drug Quality | No |
| Panel Discussion (28/28) Generic Drugs Forum 2017 | Conference/Workshop | 4/4/2017 | Generic Drug Development; Drug Quality; Inspections | No |
| CDER Microbiology Issues: A Deeper Dive | Webinar | 3/15/2017 | Drug Quality | No |
| Microbiology Assessment: Recommendations for Nonsterile Products (1/6) Microbiology Webinar | Webinar | 3/15/2017 | Drug Quality | No |
| Case Study: Micro Investigation of Contamination by Burkholderia multivorans (2/6) Microbiology Webinar | Webinar | 3/15/2017 | Drug Quality | No |
| Panel Questions and Discussion (3/6) CDER Microbiology Webinar | Webinar | 3/15/2017 | Drug Quality | No |
| Building a Better Sterility Assurance Application (4/6) CDER Microbiology Webinar | Webinar | 3/15/2017 | Drug Quality | No |
| Aseptic Processing of Biological Products: Regulatory Issues (5/6) Microbiology Webinar | Webinar | 3/15/2017 | Drug Quality | No |
| Panel Questions and Discussion (6/6) CDER Microbiology Webinar | Webinar | 3/15/2017 | Drug Quality | No |
| Draft Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions | Webinar | 3/6/2017 | Generic Drug Development | No |
Best Practices for Communication Between FDA and IND Sponsors During Drug Development: CDERLearn Course
Certificates of completion and embedded videos are no longer available. | CDERLearn Course | 2/1/2017 | FDA Meetings/Communications; IND | No |
| FDA Addresses Small Business Concerns in GDUFA II | SBIA Chronicles | 1/26/2017 | Generic Drug Development | No |
| FDA Addresses Small Business Concerns in GDUFA II | SBIA Chronicles Podcast | 1/26/2017 | Generic Drug Development | No |
FDA's Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond: CDERLearn Course
Certificates of completion and embedded videos are no longer available. | CDERLearn Course | 6/7/2021 | New Drug Development; Safety; Quality | No |
GDUFA Self-Identification (SPL) Submission – Part 1: CDERLearn Course
Certificates of completion and embedded videos are no longer available. | CDERLearn Course | 1/12/2016 | Generic Drug Development; Regulatory Submissions | No |
GDUFA Self-Identification (SPL) Submission – Part 2: CDERLearn Course
Certificates of completion and embedded videos are no longer available. | CDERLearn Course | 1/12/2016 | Generic Drug Development; Regulatory Submissions | No |
Overview of the Generic Drug User Fee Amendments of 2012 (GDUFA): CDERLearn Course
Certificates of completion and embedded videos are no longer available. | CDERLearn Course | 1/12/2016 | Generic Drug Development; User Fees | No |
Case Studies in FDA's Drug Regulatory Processes: CDERLearn Course
Certificates of completion and embedded videos are no longer available. | CDERLearn Course | 10/22/2015 | New Drug Development; NDA; IND | No |
Engaging with the FDA During New Drug Development
Certificates of completion and embedded videos are no longer available. | CDERLearn Course | 9/26/2014 | New Drug Development; FDA Meetings/Communications | No |
Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND: CDERLearn Course
Certificates of completion and embedded videos are no longer available. | CDERLearn Course | 9/17/2014 | New Drug Development; Drug Quality | No |
| CDER Presentations Library | Webinar | | New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research | No |
| CDER Webinars | Webinar | | New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research | No |
| Guidance Webinar Series | Webinar | | New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research | No |
