U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Training and Continuing Education
  3. CDERLearn
  1. Training and Continuing Education

CDERLearn

Continuing Education (CE) and training for healthcare professionals, academia, and consumers from FDA's Center for Drug Evaluation and Research (CDER)

CDERLearn

Use filters and search box to find resources

Advanced search (combine topic and search terms)

DescriptionTopicCECredits
FDA approval of Keytruda (pembrolizumab) for unresectable advanced or metastatic malignant pleural mesotheliomaCancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
7 Things to Know About Drug Shortage ManagementDrug Regulatory Process; Drug SafetyNo0
FDA approval of EnhertuCancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA’s Regulation of Dietary Supplements with Dr. Cara WelchHealth FraudYes0.5
The Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert BallDrug Development; Drug Regulatory Process; Drug Safety; Artificial IntelligenceNo0
Antibiotics: Know When and How to Use ThemDrug SafetyNo0
FDA approval of Tecelra (afamitresgene autoleucel)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Understanding Drug Recalls with Dr. Ileana ElderDrug Regulatory Process; Drug SafetyNo0
Resource Guide for Teaching FacultyBiosimilars; Drug Regulatory Process; Drug Development; Drug SafetyNo0
Utilizing Generic Drug Awareness to Improve Patient Outcomes with Dr. Sarah IbrahimDrug Regulatory Process; Drug Development; Drug Safety; Generic DrugsNo0
FDA approval of RetevmoCancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Accidental Exposures to Fentanyl Patches Continue to Be Deadly to ChildrenDrug Regulatory Process; Drug Safety; OpioidsNo0
Should You Give Kids Medicine for Coughs and Colds?Drug Regulatory Process; Drug Safety; OTC Drug RegulationsNo0
What Does FDA Approve? Part 2Drug Safety; MedWatchNo0
Is It Really 'FDA Approved'?Compounding; Drug Development; Drug Regulatory Process; Drug SafetyNo0
10 Facts about What FDA Does and Does Not ApproveCBD; Compounding; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Sunscreen: How to Help Protect Your Skin from the SunSunscreenNo0
Facts about SunscreenSunscreenNo0
MedicamentosDrug Development; Drug Regulatory Process; Drug Safety; EspañolNo0
Datos acerca de los medicamentos genéricosDrug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; EspañolNo0
Hechos Sobre Los Medicamentos GenericosDrug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; EspañolNo0
Medicamentos Genéricos: Preguntas y RespuestasDrug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; EspañolNo0
2024 PDA/ FDA Joint Regulatory ConferenceDrug Development; Drug Regulatory Process; Drug SafetyNo0
Complex Innovative Trial Design Meeting ProgramCase Study; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA approval of Ojemda (tovorafenib)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Conversations on Cancer—Strength in Numbers: Increasing Cancer Awareness While Decreasing DisparitiesCancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety; Minority HealthNo0
Conversations on Cancer: ODAC Chronicles - the Past, Present, and Future of Oncology Advisory CommitteesCancer Drugs; Drug Regulatory Process; Drug Development; Drug SafetyNo0
Considerations for Drug Products that Contain NanomaterialsDrug Regulatory Process; Drug Development; Drug SafetyNo0
Compounding Quality Center of Excellence | Engage with the Compounding Quality Center of ExcellenceCompounding; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Opioid Use Disorder, New Biosimilar, Black Family Cancer Awareness Week, & moreBiosimilars; Cancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety; Minority Health, OpioidsNo0
The Role of Artificial Intelligence in Clinical Trial Design and Research with Dr. ElZarradDrug Development; Drug Regulatory Process; Drug Safety; Artificial IntelligenceYes0.5
Practitioners’ Guide for Improving Oral Anticoagulant UseDrug Development; Drug Regulatory Process; Drug Safety; Generic DrugsNo0
14th Annual Sentinel Initiative Public WorkshopCOVID-19; Drug Regulatory Process; Drug Development; Drug SafetyNo0
6 Tip-Offs to Rip-Offs: Don't Fall for Health Fraud ScamsDrug Safety; Health FraudNo0
Accelerating Access to Critical Therapies for ALSDrug Development; Drug Regulatory ProcessNo0
Accelerating Rare disease Cures (ARC) ProgramDrug Development; Drug Regulatory Process; Rare DiseasesNo0
Achieving Data Quality and Integrity in Maximum Containment LaboratoriesDrug Development; Drug Regulatory Process; Drug SafetyNo0
Advancing Generic Drug Development: Translating Science to Approval 2023Drug Development; Drug Regulatory Process; Drug Safety; Generic DrugsNo0
Advancing Regulatory Science at FDADrug Development; Drug Regulatory ProcessNo0
Advancing Transparency and Regulatory Science Activities on the Risk Evaluation and Mitigation Strategy (REMS)Drug Regulatory Process; Drug Development; Drug SafetyYes1
Adverse Events Associated with Compounded Drugs from Outsourcing FacilitiesCase Study; Compounding; Drug Development; Drug Regulatory Process; Drug Safety; MedWatchNo0
AirflowCompounding; Drug Development; Drug Regulatory Process; Drug SafetyYes4
Application of Artificial Intelligence and Machine Learning for Precision MedicineDrug Development; Drug Regulatory Process; Drug Safety; Artificial IntelligenceNo0
Are you on a biologic medication? What you need to know about biosimilar treatment optionsBiosimilarsNo0
Areas of Customer Need for Outsourcing Facility ProductsCompounding; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Aseptic Process Simulations (Media Fills)Compounding; Drug Development; Drug Regulatory Process; Drug SafetyYes2
Bench to Bedside: Integrating Sex and Gender to Improve Human HealthDrug Development; Drug Regulatory Process; Drug Safety; Women's HealthYes1
BeSafeRx: Your Source for Online Pharmacy InformationDrug Safety: Health FraudNo0
Biological Products, Biosimilars Products, and Interchangeable Biosimilar ProductsBiosimilars; Drug Regulatory Process; Drug DevelopmentNo0
Biosimilar and Interchangeable Biologics: More Treatment ChoicesBiosimilarsNo0
Biosimilar and Interchangeable Biosimilars: Review of Scientific Concepts, Case Studies, and ResourcesBiosimilars; Drug Regulatory Process; Drug Development; Drug SafetyYes1
Biosimilar BasicsBiosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic DrugsNo0
Biosimilar Basics for PatientsBiosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic DrugsNo0
Biosimilar Manufacturing and VariationBiosimilars; Drug Regulatory Process; Drug DevelopmentNo0
Biosimilar Medications - What Health Care Providers Need to KnowBiosimilars; Drug Regulatory Process; Drug Development; Drug SafetyNo0
Biosimilar Medications - What Patients Need to KnowBiosimilars; Drug Regulatory Process; Drug Development; Drug SafetyNo0
Biosimilar Regulatory Approval PathwayBiosimilars; Drug Regulatory Process; Drug DevelopmentNo0
Biosimilares: Lo que los pacientes con diabetes deben saberBiosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; EspañolNo0
Biosimilares: Lo que los pacientes deben saberBiosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; EspañolNo0
Biosimilars 101: A Primer for Your PracticeBiosimilars; Cancer Drugs; Case Study; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women's HealthYes0.25
Biosimilars 102: Interchangeability, Extrapolation, and Immunogenicity - A Regulatory Process Primer (medscape.org)Biosimilars; Drug Regulatory Process; Drug DevelopmentYes0.25
Biosimilars Basics InfographicBiosimilars; Generic DrugsNo0
Biosimilars Curriculum Materials for Health Care Degree ProgramsBiosimilars; Case Study; Drug Development; Drug Regulatory Process; Drug Safety; Generic DrugsNo0
Biosimilars in the Real World: Perspectives for Staying Within the Scope of CareBiosimilars; Cancer Drugs; Case Study; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatchYes0.5
Biosimilars Level 1: Foundational ConceptsBiosimilars; Case Study Drug Regulatory Process; Drug DevelopmentNo0
Biosimilars Level 2: Regulatory and Scientific ConceptsCase StudyNo0
Biosimilars Multimedia Education MaterialsBiosimilars; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Biosimilars Overview for Health Care ProfessionalsBiosimilars; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Biosimilars Patient MaterialsBiosimilars; Drug Regulatory Process; Drug Development; Drug SafetyNo0
Biosimilars ResourcesBiosimilars; Case Study; Drug Regulatory Process; Drug DevelopmentNo0
Biosimilars VideosDrug Development; Biosimilars;  Drug Regulatory ProcessNo0
Biosimilars: A Review of Scientific, Regulatory, and Clinical Considerations for Health Care ProvidersBiosimilars; Drug Regulatory Process; Drug DevelopmentYes1
Biosimilars: Are they the same quality?Biosimilars; Drug Regulatory Process; Drug Development; Drug SafetyNo0
Biosimilars: What Patients Need to KnowBiosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic DrugsNo0
Biosimilars: What Patients With Diabetes Need To KnowBiosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic DrugsNo0
Biosimillars Health Care Provider MaterialsBiosimilars; Drug Regulatory Process; Drug Development; Drug SafetyNo0
Bridging Efficacy and Safety to the ObeseCancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND/Expanded Access; MedWatch; Women's HealthNo0
Bringing Clinical Research to Patients Drug Regulatory Process; Drug Development; Drug SafetyYes1
Cannabis and Cannabis-Derived Products – For Healthcare PractitionersDrug Regulatory Process; Drug Development; Drug Safety; CannabidiolYes1
CDER Conversation: Improving Medication Adherence and Patient Experience by Researching Patient Perceptions of Generic DrugDrug Development; Drug Regulatory Process; Drug Safety; Generic DrugsNo0
CDER WebinarsDrug Regulatory Process; Drug Development; Generic Drugs; OTC Drug Regulations; Biosimilars; Drug Safety; MedWatch; IND/Expanded Access; Cancer DrugsNo0
CDER’s Emerging Drug Safety Technology Meeting ProgramDrug Development; Drug Regulatory Process; Drug Safety; Artificial IntelligenceNo0
Cleanroom In-person CourseCompounding; Drug Regulatory Process; Drug DevelopmentYes13.75
Clinical Trial BasicsDrug Regulatory Process; Drug Development; Drug Safety; IND/Expanded Access; Women's HealthNo0
Clinical Trial Basics with Dr. Robert TempleDrug Regulatory Process; Drug Development; Drug Safety; IND/Expanded Access; Women's HealthYes0.5
Compounding Outsourcing Facilities Annual StudyCompounding; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Compounding Quality Center of Excellence Annual Conference 2023Compounding, COVID-19, Drug Development, Drug Regulatory Process, Drug SafetyNo0
Compounding Quality Center of Excellence Virtual ConferenceCompounding; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Conceptos ba¡sicos sobre los biosimilaresBiosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; EspañolNo0
Conversation on Paxlovid with Dr. John FarleyCOVID-19; Drug Regulatory Process; Drug Development; Drug SafetyYes0.5
Conversations on Cancer, Black History Month Program: Real Talk: Our Stories as Black Oncologists at the FDACancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety, Minority HealthNo0
Conversations on Cancer: "What's on the Horizon: Future of Cancer Care"Cancer DrugsNo0
Conversations on Cancer: Bringing Innovation to People Facing CancerCancer DrugsNo0
Conversations on Cancer: Cancer Disparities in AppalachiaCancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Conversations on Cancer: Cancer Misinformation: Truth or ConsequencesCancer Drugs, Drug Development, Drug Regulatory Process, Drug SafetyNo0
Conversations on Cancer: How Biotech Built a Blockbuster Cancer DrugCancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Conversations on Cancer: Living with Metastatic Breast CancerCancer DrugsNo0
Conversations on Cancer: National Black Family Cancer Awareness Week, Engaging the GenerationsCancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety, Minority HealthNo0
Conversations on Cancer: Seasons of Change: Oncology CareersCancer DrugsNo0
Conversations on Cancer: Transforming Patient Lives by Therapeutic and Regulatory InnovationsCancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Counseling Patients on Generic DrugsGeneric Drugs; Drug Regulatory Process; Drug Development; Drug SafetyYes1
CURE ID, A Tool for Clinicians to Report New Uses of Existing Drugs with Heather Stone and Dr. Marco SchitoCase Study; COVID-19; Drug Development; Drug Regulatory Process; Drug Safety; MedWatchYes0.5
Development and U.S. Regulation of Preventative VaccinesDrug Regulatory Process; Drug DevelopmentYes1
Drug Approval Case StudiesCase Study; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND/Expanded AccessNo0
Drug Information Soundcast in Clinical Oncology (D.I.S.C.O)Cancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women's HealthNo0
Drug Shortages with CDR Emily ThakurCOVID-19; Drug Development; Drug Regulatory Process; Drug SafetyYes0.5
Drug Shortages: Root Causes and Potential SolutionsDrug Regulatory Process; Drug DevelopmentYes1
Engaging Providers to Address Knowledge Gaps on Medication Use in Pregnancy and LactationDrug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch; Women's HealthYes1
Enhanced Drug Distribution Security: 2023 and BeyondDrug Regulatory Process; Drug SafetyYes1
Environmental Monitoring In-person CourseCompounding; Drug Regulatory Process; Drug DevelopmentYes15.25
Equity of Voices video seriesCase Study; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatchNo0
Expanded Access with Dr. Jacqueline Corrigan-CurayDrug Development; Drug Regulatory Process; Drug Safety; IND/Expanded AccessYes0.5
FDA 101: An Overview of FDA's Regulatory Review and Research ActivitiesDrug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND/Expanded Access; OTC Drug Regulations; Women's HealthNo0
FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)Disease States; Drug Development; Drug Regulatory ProcessYes0.5
FDA approval of Augtyro (repotrectinib)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA approval of Epkinly (epcoritamab-bysp)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA approval of Fruzaqla (fruquintinib)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA approval of Jemperli (dostarlimab-gxly)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA approval of Keytruda (pembrolizumab)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA approval of Lynparza (Olaparib)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA approval of OGSIVEO (nirogacestat)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA approval of Omisirge (omidubicel-onlv)Cancer Drugs, Drug Development, Drug Regulatory Process, Drug SafetyNo0
FDA approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA approval of Polivy (polatuzumab vedotin-piiq)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA approval of Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients with low-grade glioma with a BRAF V600E mutationCancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA approval of Tibsovo (ivosidenib)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA approval of Trodelvy (sacituzumab govitecan-hziy)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Women's HealthNo0
FDA approval of Verzenio (abemaciclib)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Women's HealthNo0
FDA approval of Zynyz (retifanlimab-dlwr)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA approvals of Jaypirca (pirtobrutinib) and Orserdu (elacestrant)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Women's HealthNo0
FDA approvals of Talvey and ElrexfioCancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA approvals of Tukysa (tucatinib)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA D.I.S.C.O. Burst Edition: Retevmo (selpercatinib)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA Drug Info RoundsDrug Safety; MedWatch; IND/Expanded Access; Drug Development; Drug Regulatory Process; Generic DrugsNo0
FDA Drug Information Resources and Applicability to Health Care ProfessionalsDrug Regulatory Process; Drug Development; Drug Safety; MedWatchYes1
FDA Drug Safety PodcastsDrug SafetyYes0.5
FDA Drug Topics: The Ins and Outs of Prescription Drug LabelingDrug Regulatory Process; Drug Development; Drug SafetyYes1
FDA Grand RoundsCOVID-19; Drug Regulatory Process; Drug Development; Drug Safety; MedWatch; Generic Drugs; OTC Drug Regulations; Biosimilars; IND/Expanded Access; Cancer Drugs; Women's HealthNo0
FDA Health PlaybookDrug Safety; OTC Drug Regulations; MedWatch; OpioidsNo0
FDA InsightCompounding; COVID-19; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Opioids; Women's Health; OTC Drug RegulationsNo0
FDA MedWatch and Patient SafetyMedWatch; Drug SafetyNo0
FDA Office of Clinical Pharmacology and International Society of Pharmacometrics (ISoP) Public Workshop: Using Modeling and Simulation to Select Dosages for Combination Therapies and New IndicationsCancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; IND/Expanded AccessNo0
FDA Overview of Biosimilar ProductsBiosimilars;Drug Regulatory Process; Drug DevelopmentNo0
FDA Rare Disease Day 2023Drug Development; Drug Regulatory Process; Drug Safety; Rare DiseasesNo0
FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived CompoundsDrug Development; Drug Regulatory Process; Drug Safety; IND/Expanded Access; CannabidiolNo0
FDA Review and Approval Process for Biosimilar MedicationsBiosimilars; Drug Regulatory Process; Drug Development; Drug SafetyNo0
FDA takes steps to decrease barriers for overdose reversal agents with Dr. Marta SokolowskaDrug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; OTC Drug RegulationsYes0.5
FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe useDrug Regulatory Process; Drug Safety; OpioidsYes0.5
FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditionsDrug Regulatory Process; Drug Development; Drug SafetyYes0.5
FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)Drug Regulatory Process; Drug Development; Drug SafetyYes0.5
FDA/CDER Office of Clinical Pharmacology and International Society of Pharmacometrics (ISoP) Public Workshop: Using Modeling and Simulation to Evaluate the Effects of Intrinsic and Extrinsic FactorsCancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA’s Office of Orphan Products Development (OOPD) – An Overview and UpdateRare Diseases; Drug Regulatory Process; Drug Development; Drug SafetyYes1
FDA’s Role in Postmarketing Drug Safety SurveillanceDrug Regulatory Process; Drug Development; Drug Safety; MedWatchYes1
FDA's Biomarker Qualification ProgramDrug DevelopmentNo0
FDA's Overdose Prevention Framework with Dr. Marta SokolowskaDrug Regulatory Process; Drug Development; Drug Safety; MedWatch; Opioids; Cancer DrugsYes0.5
FDA's Regulation of Dietary Supplements with Dr. Cara WelchDrug Development; Drug Regulatory Process; Drug SafetyYes0.5
FDA's Role in Public Health: Drug Efficacy, Safety, Quality, and BeyondDrug Regulatory ProcessNo0
FDA's Work to Combat the COVID-19 PandemicCOVID-19; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Fraudulent Products – Hidden Ingredients and Unproven Claims in Products Marketed as Dietary SupplementsDrug Regulatory Process; Drug Safety, Health FraudYes1
Frequently Asked Questions about Labeling for Prescription MedicinesDrug Regulatory Process; Drug Development; Drug SafetyYes1
GDUFA II Videos and ResourcesDrug Development; Generic DrugsNo0
Generics and BiosimilarsBiosimilars; Drug Regulatory Process; Drug Development; Generic DrugsNo0
Generics-at-a-Glance with Dr. Sarah IbrahimDrug Development; Drug Regulatory Process; Drug Safety; Generic DrugsYes0.5
Health Equity Forum PodcastCOVID-19; Drug Development; Drug Regulatory Process; Drug Safety; Women's HealthNo0
Health Fraud Product DatabaseDrug Safety; Health FraudNo0
Health Fraud ScamsDrug Safety: Health FraudNo0
How FDA and ISMP Utilize Medication Error Reports to Improve Drug SafetyDrug Regulatory Process; Drug SafetyYes1
How to Avoid Medication Errors with Pen InjectorsDrug Safety; MedWatchYes1
How to Use the Consumer Complaint System and MedWatchDrug Safety; MedWatchNo0
Hyperemesis Gravidarum: New Research and InsightsWomen's Health; Drug SafetyYes1
Incorporating Biosimilars Into the Management of Patients With Immunological ConditionsBiosimilars; Cancer Drugs; Case Study; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women's HealthYes1
Increasing the Efficiency of Biosimilar Development ProgramsBiosimilars;Drug Regulatory Process; Drug DevelopmentNo0
Increasing the Efficiency of Biosimilar Development Programs 2023Biosimilars; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Information about Medications for Opioid Use Disorder (MOUD)Drug Regulatory Process; Drug Safety; OpioidsNo0
Insanitary Conditions and Sterility AssuranceCompounding; Drug Development; Drug Regulatory Process; Drug SafetyYes4
Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug ProductsDevelopment; Drug Regulatory Process; Drug Safety; Generic DrugsNo0
Interchangeable Biological ProductsBiosimilarsNo0
Interchangeable BiosimilarsBiosimilarsNo0
Investigations and Corrective and Preventive Actions (CAPA) 2023Compounding; Drug Development; Drug Regulatory Process; Drug SafetyYes5
Investigations and Corrective and Preventive Actions (CAPA) Virtual Course 2024Compounding; Drug Regulatory Process; Drug DevelopmentNo0
Joint US FDA - Health Canada ICH Public MeetingDrug Development; Drug Regulatory Process; Drug Safety; IND/Expanded AccessNo0
Leveraging Health Literacy and Patient Preferences to Reduce Hypoglycemia Events in Patients with Type 2 DiabetesDrug SafetyNo0
Maximizing Benefits and Minimizing Harms from AntibioticsDrug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatchNo0
Medical Extended Reality: Applications and ChallengesDrug Regulatory Process; Drug Development; Drug SafetyNo0
Medication Health Fraud and Avoiding Medication Scams with Cynthia NgDrug Safety; MedWatch; Generic Drugs; Drug Regulatory Process, Health FraudYes0.5
MedWatch, Your Report Can Make a Difference with Dr. Gerald Dal PanDrug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatchYes0.5
Minority Health and Health Equity WebinarsDrug Development; Drug Regulatory Process; Drug Safety, Minority HealthNo0
Naltrexone Injection for Opioid Use Disorder - FDA's Efforts to Reduce Medication ErrorsDrug Regulatory Process; Drug Safety; MedWatch; OpioidsNo0
Navigating the World of Online Pharmacies with CDR Lysette DeshieldsDrug Regulatory Process; Drug Safety; Health FraudYes0.5
OMHHE Health Equity Forum Podcast - Toward Improving Race and Ethnicity Data in HealthcareDrug Development; Drug Regulatory ProcessNo0
Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot ProgramCancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and GenderCancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch; Opioids; Women's HealthNo0
Outsourcing Facility GuideCompounding; Drug Development; Drug Regulatory Process; Drug SafetyYes1.75
Overcoming Reluctance and Enhancing Biosimilar AdoptionBiosimilars; Drug Regulatory Process; Drug Development; Drug SafetyNo0
Overcoming Reluctance and Enhancing Biosimilar Adoption (Medscape)Biosimilars; Drug Regulatory Process; Drug Development; Drug SafetyYes0.5
Overview of Expanded Access (EA) Program and EA eRequest SiteIND/Expanded Access; Rare Diseases; Drug Regulatory Process; Drug Development; Drug SafetyYes1
Overview of FDA role regulating and approving drugsDrug Development; Drug Regulatory Process; Drug Safety; MedWatchNo0
An Overview of FDA’s Project Facilitate Oncology Expanded Access ProgramCancer Drugs; Disease States; Drug Development; Drug Regulatory ProcessYes1
PCOS Revisited: Diagnosis, Management, and Future Needs Women's Health; Drug SafetyYes1
Personnel Gowning in Sterile Drug ProductionCompounding; Drug Development; Drug Regulatory Process; Drug SafetyYes0.5
Pregnancy and Lactation Medication Information for the Healthcare ProviderWomen's Health; Drug Regulatory Process; Drug SafetyYes1
Prescribe with ConfidenceDrug Regulatory Process; Drug Safety; OpioidsNo0
Primary Care Providers Can Prescribe with ConfidenceDrug Regulatory Process; Drug Safety; OpioidsNo0
Process Validation Virtual CourseCompounding; Drug Regulatory Process; Drug DevelopmentYes15
Public meeting: FDA Rare Disease Day 2024Drug Regulatory Process; Drug Safety Rare DiseasesYes4.75
Putting the Patient into Perspective: Strategies for Educating Patients about BiosimilarsBiosimilars; Cancer Drugs; Case Study; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women's HealthYes0.25
Q&A with FDA PodcastCOVID-19; Drug Regulatory Process; Drug Development; Drug Safety; MedWatchYes0.5
Quality Management Systems Virtual CourseCompounding; Drug Regulatory Process; Drug DevelopmentYes15
Rare Diseases - Challenges and Progress in Drug DevelopmentDrug Development; Drug Safety; Rare DiseasesYes1
READDI for the next pandemicDrug Development; Drug Regulatory Process; Drug SafetyNo0
Regulatory Framework for Human Drug CompoundingCompounding; Drug Development; Drug Regulatory Process; Drug SafetyYes1.5
Regulatory Science at CDER VideosDrug Regulatory Process; Drug DevelopmentNo0
Reporting and Public Viewing of Individual Case Safety Reports (ICSRs)Drug Regulatory Process; Drug Development; Drug Safety; MedWatchYes1
Reporting Unlawful Sales of Medical Products on the InternetDrug SafetyNo0
Risk Evaluation and Mitigation Strategies (REMS) Program Part 1Drug Development; Drug Regulatory Process; Drug Safety; Generic DrugsNo0
Risk Evaluation and Mitigation Strategies (REMS) Program Part 2Drug Development; Drug Regulatory Process; Drug Safety; Generic DrugsNo0
Safe Opioid DisposalDrug Regulatory Process; Drug Development; Drug Safety; MedWatch; Generic Drugs; Cancer Drugs;OpioidsNo0
Safety Labeling Changes for Leukotriene Receptor Antagonists and Decisions Behind a Boxed WarningDrug Regulatory Process; Drug Development; Drug Safety; MedWatchYes1
SBIA ChroniclesDrug Regulatory ProcessNo0
Second Annual FDA ASCO WORKSHOP on Getting the Dosage RightCancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Stability and Beyond Use DatesCase Study; Compounding; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch; Case StudyYes4
State of Outsourcing Facility Sector and Possibilities for the FutureCompounding; Drug Development; Drug Regulatory Process; Drug SafetyNo0
A Step Forward in the Treatment of Opioid and Alcohol Dependence with Dr. Iilun Murphy and Dr. Marta SokolowskaDrug Regulatory Process; Drug Safety; Generic Drugs; OpioidsYes0.5
Sterile Drug Compounding In-person CourseCompounding; Drug Regulatory Process; Drug DevelopmentYes16
Sterility Testing: Common MisconceptionsCompounding; Drug Development; Drug Regulatory Process; Drug SafetyYes0.75
Successes and Opportunities in Modeling and Simulation for FDADrug Development; Drug Regulatory ProcessNo0
Summary Report for BiosimilarsBiosimilars; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Supplier/Contractor Qualification and ManagementCompounding; Drug Development; Drug Regulatory Process; Drug SafetyYes4
Switching Between Biosimilars and Their Reference Counterparts with Dr. Sarah YimBiosimilars; Drug Regulatory Process; Drug Development; Drug SafetyYes0.5
The Current Status of Oral Phenylephrine as a Nasal Decongestant with Dr. Theresa Michele and Dr. Ilisa BernsteinDrug Regulatory Process; Drug Safety; OTC Drug RegulationsYes0.5
The FDA Bad Ad Program and Prescription Drug PromotionDrug Regulatory Process; Drug SafetyNo0
The FDA Process for Approving Generic DrugsDrug Regulatory Process; Drug Development; Generic DrugsNo0
The Future of Clinical Trials, The Real Cost Campaign, and Sun Safety TipsDrug Development; Drug Regulatory Process; Drug Safety; SuncreenNo0
The Role of Pharmacodynamic Biomarkers in Biosimilar Drug DevelopmentBiosimilars; Drug Development; Drug Regulatory Process; Drug SafetyNo0
The Safety Evaluation and Surveillance of Generic DrugsGeneric Drugs; Drug Regulatory Process; Drug Development; Drug SafetyYes1.5
Topics in Public HealthBiosimilars; Cancer Drugs; Case Study; Compounding; COVID-19; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND/Expanded Access; MedWatch; Opioids; OTC Drug Regulations; Women's HealthYes1
Treatment Using Medication for Opioid Use Disorder Can Save LivesDrug Regulatory Process; Drug Safety; OpioidsNo0
Understanding Generic Narrow Therapeutic Index DrugsGeneric Drugs; Drug Regulatory Process; Drug Development; Drug SafetyYes1
Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesityDrug Regulatory Process; Drug Development; Drug SafetyYes0.5
Update on FDA's ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesityDrug Development; Drug Regulatory Process; Drug Safety; MedWatchNo0
Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug ProductsDrug Development; Drug Regulatory Process; Drug SafetyNo0
What does FDA regulate?Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; OTC Drug Regulations; Women's HealthNo0
What is a Biosimilar?Biosimilars; Drug Regulatory Process; Drug DevelopmentNo0
What is a Biosimilar? (Spanish)Biosimilars; Drug Regulatory Process; Drug Development; EspañolNo0
Where and How to Dispose of Unused MedicinesDrug Safety; OpioidsNo0
Why Does the FDA Exist?Drug Development; Drug Regulatory Process; Drug SafetyNo0
FDA Drug Topics WebinarsBiosimilars; Cancer Drugs; Cannabidiol; Compounding; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Health Fraud; IND/Expanded Access; Opioids; Rare DiseasesYes1
FDA approvals of Augtyro (repotrectinib) and Krazati (adagrasib)Cancer Drugs; Drug Development; Drug Regulatory Process; Drug SafetyNo0
Real-World Data and Evidence Generation with Dr. Hilary MarstonDrug Development; Drug Regulatory Process; Drug Safety; Artificial IntelligenceNo0
Medicamentos biosimilares: Lo que los pacientes deben saberBiosimilars; Drug Regulatory Process; Drug Development; Drug SafetyNo0
What is Accelerated Approval?Cancer Drugs; Drug Regulatory Process; Drug Development; Drug SafetyNo0
How are Cancer Drugs Approved?Cancer Drugs; Drug Regulatory Process; Drug Development; Drug SafetyNo0
FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopauseWomen's Health; Drug SafetyNo0

Additional Resources

 


Sub-Topic Paragraphs

Paragraph Header
Contact Us

Contact Point
Office of Communications
10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993

Toll Free
(855) 543-3784
(301) 796-3400

Hours Available

CDER Division of Drug Information

For Latest Updates Follow

Contact Point Twitter

@FDA_Drug_Info

Your source for the latest drug information.
Know the moment it happens.


Back to Top