| 6020.14, Rev. 2 | Office of New Drugs | Interdisciplinary Review Team for Cardiac Safety Studies | New Drug Review | 10/21/2024 |
| 6030.9 | Office of New Drugs | Review Practice: Good Review Management Principles and Practices for Effective IND Development and Review | New Drug Review | 4/29/2013 |
| 5015.14 | Office of Pharmaceutical Quality | Prioritization of Solicited DMF Amendments Associated With ANDAs or PASs not Concurrently Under Assessment | Regulatory Review and Scientific Policies | 5/7/2024 |
| 5018.3 | Office of Pharmaceutical Quality | Implementation of Established Conditions as Described in ICH Q12 | Regulatory Review and Scientific Policies | 10/16/2024 |
| 7610.1 | Office of Strategic Programs | CDER Records Management | Information Technology | 3/22/2024 |
| 6702.3 | Office of Surveillance and Epidemiology | Review of Proposed Methodological Approaches to Assess a Risk Evaluation and Mitigation Strategy (REMS) | Drug Safety | 3/25/2024 |
| 6702.1 | Office of Surveillance and Epidemiology | Review of Risk Evaluation and Mitigation Strategy (REMS) Assessment Reports | Drug Safety | 3/25/2024 |
| 5017.8 | Office of Pharmaceutical Quality | Responsibilities for the Assessment of In Vitro Testing for Oral Drug Products Administered Via Enteral Feeding Tube | Regulatory Review and Scientific Policies | 8/31/2023 |
| 5016.8 Rev. 1 | Office of Pharmaceutical Quality | Using Four-Part Harmony in Quality-Related Assessment Communications | Regulatory Review and Scientific Policies | 8/25/2023 |
| 4301.1 Rev. 3 | Office of Medical Policy | CDER Medical Policy Council | Leadership and Mission | 2/23/2021 |
| 5021.5 Rev. 1 | Office of Pharmaceutical Quality | Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests | Regulatory Review and Scientific Policies | 12/21/2023 |
| 6021.1 Rev.1 | Office of New Drugs | NDAs/BLAs: Financial Disclosure | New Drug Review | 10/9/2024 |
| 4100.2 | Office of Translational Sciences | CDER Staff Participation in Public Private Partnerships and Consortia | Regulatory Review and Scientific Policies | 4/21/2023 |
| 5100.3 | Office of Clinical Pharmacology | OCP Prioritization, Triage, and Review Process for INDs and Pre-INDs | Regulatory Review and Scientific Policies | 3/30/2023 |
| 4651.3 Rev. 2 | Office of Management | PHS Commissioned Corps Awards | Staff Resources and Services | 10/10/2024 |
| 5015.13 | Office of Pharmaceutical Quality | Quality Assessment for Products in Expedited Programs | Regulatory Review and Scientific Policies | 11/1/2022 |
| 5022.0 | Office of Pharmaceutical Quality | Roles and Responsibilities of FDA Liaisons to Standards Development Organizations | Regulatory Review and Scientific Policies | 12/7/2022 |
| 5015.12 | Office of Pharmaceutical Quality | Process for Evaluating Emerging Technologies Related to Quality | Regulatory Review and Scientific Policies | 11/29/2022 |
| 5100.6 | Office of Translational Science | Policy and Procedures for Creating an Interest Group in the Office of Biostatistics | Regulatory Review and Innovation | 6/23/2022 |
| 5019.2 | Office of Pharmaceutical Quality | Assessment of the Appropriate Net Container Content for Injectable Drug and Biological Products | Regulatory Review and Scientific Policies | 12/5/2024 |
| 5223.6 | Office of Generic Drugs | Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA | Generic Drug Review | 6/7/2022 |
| 5220.3 | Office of Generic Drugs | Communicating Certain Deficiencies Identified During Filing Review of ANDAs | Generic Drug Review | 9/28/2017 |
| 5240.10 | Office of Generic Drugs | Classifying Approved New Drug Products and Drug-device Combination Products as Complex Products for Generic Drug Development Purposes | Generic Drug Review | 4/13/2022 |
| 5019.1 Rev.1 | Office of Pharmaceutical Quality | Allowable Excess Volume/Content in Injectable Drug and Biological Products | Regulatory Review and Scientific Policies | 12/23/2024 |
| 6050.2 Rev. 1 | Office of Management | Effect of Failure to Pay BsUFA Fees | Staff Resources and Services | 10/05/2023 |
| 5021.1 Rev.1 | Office of Pharmaceutical Quality | Naming of Drug Products Containing Salt Drug Substances | Regulatory Review and Scientific Policies | 12/2/2022 |
| 5021.2 | Office of Pharmaceutical Quality | Evaluating Color Additives and Flavors Intended for Oral Drug Products Submitted or Referenced in INDs and NDAs | Regulatory Review and Scientific Policies | 6/3/2021 |
| 4657.0 Rev.1 | Office of Management | CDER’s Time, Attendance, and Leave Recording Policy | Staff Resources and Services | 5/19/2021 |
| 7600.10 | Office of Strategic Programs | CDER Master Data Management | Information Technology | 4/15/2022 |
| 7610.8 | Office of Strategic Programs | Electronic and Digital Signatures for Records Management | Drug | 8/12/2022 |
| 6720.4 | Office of Surveillance and Epidemiology | Procedures for Sharing Non-public Information on Pending Proposed Proprietary Names | Drug Safety | 9/21/2016 |
| 6030.3 Rev.1 | Office of New Drugs | Emergency Investigational New Drug Application Process During and After Normal Business Hours | New Drug Review | 1/13/2025 |
| 5241.3 Rev.1 | Office of Generic Drugs and Office of Pharmaceutical Quality | Good Abbreviated New Drug Application Assessment Practices | Generic Drug Review | 10/6/2023 |
| 5240.3 Rev.6 | Office of Generic Drugs | Prioritization of the Review of Original ANDAs, Amendments, and Supplements | Generic Drug Review | 12/14/2022 |
| 5220.5 Rev.2 | Office of Generic Drugs | Issuance of Information Requests and/or Discipline Review Letters for ANDAs under the Reauthorization of GDUFA | Generic Drug Review | 10/5/2022 |
| 5220.1 | Office of Generic Drugs | Receiving and Processing a Request for Voluntary Withdrawal of an Approved ANDA | Generic Drug Review | 1/25/2023 |
| 5200.14 Rev.1 | Office of Generic Drugs | Filing Review of Abbreviated New Drug Applications | Generic Drug Review | 10/2/2023 |
| 5200.12 | Office of Generic Drugs and Office of Pharmaceutical Quality | Communicating Abbreviated New Drug Application Review Status Updates with Industry | Generic Drug Review and Regulatory Review and Scientific Policies | 10/5/2022 |
| 5200.7 Rev.1 | Office of Generic Drugs | ANDA Amendments and Supplements Reviewed by the Division of Filing Review | Generic Drug Review | 11/29/2024 |
| 5016.6 | Office of Pharmaceutical Quality | Change in Hard Gelatin Capsule Supplier | Regulatory Review and Scientific Policies | 12/20/2024 |
| 5014.1 Rev.1 | Office of Pharmaceutical Quality | Understanding CDER's Risk-Based Site Selection Model | Regulatory Review and Scientific Policies | 6/26/2023 |
| 5001.1 | Office of Pharmaceutical Quality | Drug Product Distribution After a Complete Response Action to a Changes Being Effected Supplement | Regulatory Review and Scientific Policies | 12/30/2024 |
| 4410.1 Rev. 1. | Office of Communications | FDA Pharmacy Student Experiential Program | Public Outreach | 8/28/2019 |
| 5242.1 | Office of Generic Drugs | Transfer of Ownership | Generic Drug Review | 8/26/2020 |
| 6701.4 | Office of Surveillance and Epidemiology | Notifying Applicants of Sentinel Analyses and Results | Drug Review | 8/17/2020 |
| 6702.2 | Office of Surveillance and Epidemiology | Determination of the Need for and Review of a New REMS | Drug Review | 6/18/2020 |
| 5220.2 | Office of Generic Drugs | Conversion of ANDA Approval to Tentative Approval Because of Court Order | Generic Drug Review | 6/11/2020 |
| 4121.3 | Office of the Center Director | Collaborative Identification, Evaluation, and Resolution of a Newly Identified Safety Signal (NISS) | Leadership and Mission | 4/30/2020 |
| 6701.1 | Office of Surveillance and Epidemiology | Procedures for DMEPA Intra-Center Consult to DMPP on Patient-Oriented Labeling Submitted with Human Factors Validation Study Protocols | Drug Safety | 9/18/2019 |
| 5220.8 | Office of Generic Drugs | Evaluating Requests for and Conducting Product Development and Pre-Submission Pre-ANDA Meetings | Generic Drug Review | 10/5/2022 |
| 4191.1 | Office of New Drugs | Risk Evaluation and Mitigation Strategies Modifications and Revisions | New Drug Review | 6/29/2020 |
| 6004.3 | Office of New Drugs | Safety Labeling Changes Under Section 505(o)(4) of the FD&C Act | New Drug Review | 11/07/2024 |
| 6720.5 | Office of Surveillance and Epidemiology | Procedures for Handling Requests for Nonproprietary Name Suffix Review for Biological Products Newly Licensed Under Section 351of the PHS Act | Drug Safety | 3/7/2019 |
| 6701.3 Rev.1 | Office of Surveillance and Epidemiology | Development of a Single, Shared System (SSS) Risk Evaluation and Mitigation Strategy (REMS) or a Separate REMS with Elements to Assure Safe Use (ETASU): Responsibilities and Procedures | Drug Safety | 10/28/2020 |
| 4000.1 Rev.6 | Office of Management | Developing and Issuing MAPPs for CDER | Staff Resources and Services | 9/9/2021 |
| 4112.2 Rev.1 | Office of Executive Programs | Sharing Nonpublic Information with Federal Government Officials. | Regulatory Policy and Information Disclosure | 10/27/2022 |
| 4160.2 Rev.1 | Office of the Center Director | Prioritization of Requests for Training and Visits by Foreign Regulatory Agencies and International Regulatory Organizations | Leadership and Mission | 11/9/2022 |
| 7400.13 | Office of New Drugs | Determining the Established Pharmacologic Class for Use in the Highlights of Prescribing Information | New Drug Review | 7/25/2018 |
| 4200.1 Rev.1 | Office of the Center Director | Procedures for Review of Protocols Referred By DEA That use Schedule I controlled Substances and Drugs | Leadership and Mission | 11/12/2020 |
| 4200.2 Rev.2 | Office of the Center Director | Forecasting Schedule I and II Substance and Drug Needs | Leadership and Mission | 5/8/2024 |
| 4200.3 Rev.2 | Office of the Center Director | Consulting the Controlled Substance Staff on Abuse Liability, Drug Dependence, Risk Management, and Drug Scheduling | Drug Safety | 10/26/2022 |
| 4601.3 Rev.2 | Office of Management | Children in the Workplace | Staff Resources and Services | 1/22/2021 |
| 4516.1 Rev. 1 | Office of Communications | Criteria for Developing and Publishing Digital Content on the CDER External Web Site | Public Outreach | 3/12/2020 |
| 4512.2 Rev.2 | Office of Strategic Programs | Conducting Effective Meetings in CDER: Remote Access Considerations | Information Technology | 12/8/2021 |
| 4510.2 Rev.2 | Office of Regulatory Policy | CDER Clearance of FDA Related Articles,Speeches and Other Publications | Regulatory Policy and Information Disclosure | 9/17/2020 |
| 4510.1 Rev.2 | Office of Communications | CDER Process for Authorizing Staff to Participate in External Events | Public Outreach | 11/25/2022 |
| 4520.1 Rev. 2 | Office of Communications | Communicating Drug Approval Information | Public Outreach | 11/10/2022 |
| 5017.1Rev.1 | Office of Pharmaceutical Quality | Office of Biotechnology Products and Office of Pharmaceutical Manufacturing Assessment, Interactions on BLA Assessments | Regulatory Review and Scientific Policies | 12/2/2022 |
| 5015.7 Rev.1 | Office of Pharmaceutical Quality | Environmental Assessments | Regulatory Review and Scientific Policies | 11/23/2022 |
| 5015.6 Rev.1 | Office of Pharmaceutical Quality | Review of Grouped Product Quality Supplements | Regulatory Review and Scientific Policies | 12/9/2022 |
| 5015.5 Rev.1 | Office of Pharmaceutical Quality | CMC Reviews of Type III DMF's for Packaging Materials | Regulatory Review and Scientific Policies | 12/9/2022 |
| 5015.8 | Office of Pharmaceutical Quality | Acceptance Criteria for Residual Solvents | Regulatory Review and Scientific Policies | 12/1/2022 |
| 5016.1 | Office of Pharmaceutical Quality | Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review | Regulatory Review and Scientific Policies | 1/8/2025 |
| 5040.1 | Office of Pharmaceutical Quality | Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q) | Regulatory Review and Scientific Policies | 12/7/2022 |
| 5100.4 Rev.1 | Office of Translational Sciences | Scientific Interest Groups: Criteria and Policies. | Regulatory Review and Innovation | 9/1/2021 |
| 5210.4 Rev 3 | Office of Generic Drugs | Assessment of Bioequivalence Studies with Clinical Endpoints in ANDAs | Generic Drug Review | 4/28/2023 |
| 5210.5 Rev.3 | Office of Generic Drugs | Review of Investigational New Drug Applications (Bio-INDs) by the Office of Generic Drugs | Generic Drug Review | 4/14/2022 |
| 5230.3 Rev.2 | Office of Generic Drugs | Generic Drug Labeling Revisions Covered Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act | Generic Drug Review | 12/13/2023 |
| 6020.4 Rev.3 | Office of New Drugs | Classifying Resubmissions of Original NDAs, BLAs, and Efficiacy Supplements in Response to Action Letters | New Drug Review | 10/21/2024 |
| 6020.2 Rev.1 | Office of New Drugs | Applications for Parenteral Products in Plastic Immediate Containers | New Drug Review | 12/19/2023 |
| 6010.9 | Office of New Drugs | Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments | New Drug Review | 3/9/2009 |
| 6010.8 Rev.2 | Office of New Drugs | NDAs and BLAs: Communication to Applicants of Planned Review Timelines | New Drug Review | 9/19/2024 |
| 6010.5 | Office of New Drugs | NDAs: Filing Review Issues | New Drug Review | 3/27/2018 |
| 6010.2 | Office of New Drugs | Responsibilities for Tracking and Communicating the Status of Postmarketing Requirements and Commitments | New Drug Review | 7/28/2009 |
| 5210.9 Rev.1 | Office of Pharmaceutical Quality | Review of Botanical Drug Products | Regulatory Review and Scientific Policies | 1/21/2022 |
| 6004.2 Rev.2 | Office of New Drugs | Procedures for Completing and Processing the Form "Annual Status Report Review Form: PMR and PMC Summary" | New Drug Review | 9/27/2017 |
| 4190.1 Rev.4 | Office of the Center Director | Drug Shortage Management | Medical Policy | 2/1/2024 |
| 6001.1 Rev. 1 | Office of Executive Programs | Special Government Employees Representing Sponsors Before CDER | Executive Secretariat | 9/16/2022 |
| 5310.7 Rev.1 | Office of Pharmaceutical Quality | Acceptability of Standards From Alternative Compendia (BP/EP/JP) | Regulatory Review and Scientific Policies | 9/18/2024 |
| 5310.3 Rev.2 | Office of Pharmaceutical Quality | Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes | Regulatory Review and Scientific Policies | 12/19/2024 |
| 6030.1 Rev.3 | Office of New Drugs | IND Clinical Holds | New Drug Review | 2/20/2018 |
| 6020.8 Rev 1 | Office of New Drugs | NDAs/BLAs/Efficacy Supplements: Action Packages and Taking Regulatory Actions | New Drug Review | 6/14/2016 |
| 6020.5 Rev. 2 | Office of New Drugs | Good Review Practice: OND Review Management of INDs and NDAs for Nonprescription Drug Products | New Drug Review | 6/25/2018 |
| 7600.6 Rev. 2 | Office of Strategic Programs | Requesting and Accepting Non-Archivable Records in Electronic Format for New Drug Applications | Information Technology | 4/24/2023 |
| 7500.1 Rev. 2 | Office of New Drugs | Regulatory Project Management Coordinating Committee | New Drug Review | 9/5/2018 |
| 7400.1 Rev.2 | Office of New Drugs | Management of CDER Pharmacology/Toxicology Coordinating Committee and Its Associated Subcommittees and Working Groups | New Drug Review | 5/17/2016 |
| 6720.2 Rev.2 | Office of Surveillance and Epidemiology | Procedures for Handling Requests for Proprietary Name Review | Drug Safety | 8/8/2024 |
| 6700.5 | Office of Surveillance and Epidemiology | Responding to Requests For Waivers of Postmarketing Safety Reporting Requirements under 21 CFR §§ 314.80 (NDAs), 314.98 (ANDAs), and 600.80 (BLAs) | Drug Safety | 7/25/2022 |
| 6700.9 | Office of Surveillance and Epidemiology | 6700.9 (PDF - 121KB) FDA Posting of Potential Signals of Serious Risks Identified by the Adverse Event Reporting System | Drug Safety | 9/10/2019 |
| 6610.1 Rev. 2 | Office of Translational Sciences and Biostatistics | Statistical Policy Council | Regulatory Review and Innovation | 6/1/2021 |
| 6050.1 Rev. 2 | Office of Management | Effect of Failure to Pay PDUFA Fees | Staff Resources and Services | 12/01/2021 |
| 6030.8 Rev.1 | Office of New Drugs | INDs: Exception from Informed Consent Requirements for Emergency Research | New Drug Review | 11/17/2014 |
| 6030.6 | Office of New Drugs | INDs: Processing Treatment INDs and Treatment Protocols | New Drug Review | 12/9/2011 |
| 6030.2 Rev.1 | Office of New Drugs | INDs: Review of Informed Consent Documents | New Drug Review | 5/2/2014 |
| 6020.3 Rev.2 | Office of New Drugs | Review Designation Policy: Priority (P) and Standard (S) | New Drug Review | 6/25/2013 |
| 5240.5 Rev.3 | Office of Generic Drugs | ANDA Suitability Petitions | Generic Drug Review | 9/29/2023 |
| 7620.6 Rev.1 | Office of the Center Director | Procedure for Review and Clearance of ICH Guidelines | Information Technology | 3/19/2024 |
| 7610.6 Rev.1 | Office of Strategic Programs | CDER Electronic Application Forms Oversight | Information Technology | 10/7/2022 |
| 6025.4 | Office of New Drugs | Good Review Practice: Refuse to File | New Drug Review | 9/5/2018 |
| 7412.1 Rev.2 | Office of New Drugs | Management of CDER Executive Carcinogenicity Assessment Committee and Communication of Committee Proceedings | New Drug Review | 6/8/2018 |
| 7412.2 Rev.1 | Office of New Drugs | Management of CDER Carcinogenicity Assessment Committee and Communication of Committee Proceedings | New Drug Review | 6/7/2018 |
| 6025.6 Rev.1 | Office of New Drugs | Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics | New Drug Review | 2/28/2024 |
5016.3
Rev. 1 | Office of Pharmaceutical Quality | Responsibility for the Quality Assessment of Products Containing Peptide or Protein Drug Substances | Regulatory Review and Scientific Policies | 6/21/2023 |
| 7600.11 | Office of Strategic Programs | CDER Electronic Record Keeping Systems | Information Technology | 8/4/2021 |
| 4100.1 Rev.2 | Office of Management | CDER Co-Sponsorship Agreements for Events | Staff Resources and Services | 6/21/2022 |
| 7700.5 Rev.1 | Office of Translational Sciences | Critical Path Innovation Meetings Policy and Procedures | Regulatory Review and Innovation | 4/14/2021 |
| 4001.1 | Office of Management | Developing, Issuing and Maintaining Standard Operating Procedures for CDER | Staff Resources and Services | 2/1/2023 |
| 6025.7 Rev.1 | Office of New Drugs | Good Review Practice: Review of Marketing Applications for Breakthrough Therapy-Designated Drugs and Biologics That Are Receiving an Expedited Review | New Drug Review | 2/28/2024 |
| 4651.4 Rev.1 | Office of Management | CDER Incentive Awards Program (Cash and Time-off) | Staff Resources and Services | 7/16/2020 |
| 4800.2 Rev.1 | Office of the Center Director | Continuity of Operations (COOP) | Leadership and Mission | 7/21/2021 |
| 7610.7 Rev.1 | Office of Strategic Programs | CDER Data Standards Program | Information Technology | 8/31/2021 |
| 5241.2 Rev. 1 | Office of Generic Drugs | Consolidation of ANDAs by the Office of Generic Drugs | Generic Drug Review | 8/19/2020 |
| 6001.2 Rev.2 | Office of Communications | CDER Network Of Experts | Leadership and Mission | 2/1/2024 |
| 5018.2 | Office of Pharmaceutical Quality | NDA Classification Codes | Regulatory Review and Scientific Policies | 12/6/2022 |
