CDERLearn
Training and education for healthcare professionals, academia, and consumers from FDA's Center for Drug Evaluation and Research (CDER)
Continuing Education (CE) Credits Update
[8/12/2025] The FDA's accredited Continuing Education program is unable to process CE applications or CE credits at this time. We apologize for the inconvenience.
For assistance in retrieving previously earned CE credit certificates, email the FDA CE Team at FDACETeam@fda.hhs.gov.
| Description | Topic |
|---|---|
| FDA approval of Bizengri (zenocutuzumab-zbco) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| Overview of our role regulating and approving drugs | Drug Development; Drug Regulatory Process; Drug Safety |
| 7 Things to Know About Drug Shortage Management | Drug Regulatory Process; Drug Safety |
| FDA approval of Enhertu | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA’s Regulation of Dietary Supplements with Dr. Cara Welch | Health Fraud |
| The Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert Ball | Drug Development; Drug Regulatory Process; Drug Safety; Artificial Intelligence |
| Antibiotics: Know When and How to Use Them | Drug Safety |
| FDA approval of Tecelra (afamitresgene autoleucel) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| Understanding Drug Recalls with Dr. Ileana Elder | Drug Regulatory Process; Drug Safety |
| Resource Guide for Teaching Faculty | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety |
| Utilizing Generic Drug Awareness to Improve Patient Outcomes with Dr. Sarah Ibrahim | Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs |
| FDA approval of Retevmo | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| Accidental Exposures to Fentanyl Patches Continue to Be Deadly to Children | Drug Regulatory Process; Drug Safety; Opioids |
| Should You Give Kids Medicine for Coughs and Colds? | Drug Regulatory Process; Drug Safety; OTC Drug Regulations |
| What Does FDA Approve? Part 2 | Drug Safety; MedWatch |
| Is It Really 'FDA Approved'? | Compounding; Drug Development; Drug Regulatory Process; Drug Safety |
| 10 Facts about What FDA Does and Does Not Approve | CBD; Compounding; Drug Development; Drug Regulatory Process; Drug Safety |
| Sunscreen: How to Help Protect Your Skin from the Sun | Sunscreen |
| Facts about Sunscreen | Sunscreen |
| Medicamentos | Drug Development; Drug Regulatory Process; Drug Safety; Español |
| Datos acerca de los medicamentos genéricos | Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español |
| Hechos Sobre Los Medicamentos Genericos | Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español |
| Medicamentos Genéricos: Preguntas y Respuestas | Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español |
| 2024 PDA/ FDA Joint Regulatory Conference | Drug Development; Drug Regulatory Process; Drug Safety |
| Complex Innovative Trial Design Meeting Program | Case Study; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Ojemda (tovorafenib) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| Conversations on Cancer—Strength in Numbers: Increasing Cancer Awareness While Decreasing Disparities | Cancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety; Minority Health |
| Conversations on Cancer: ODAC Chronicles - the Past, Present, and Future of Oncology Advisory Committees | Cancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety |
| Considerations for Drug Products that Contain Nanomaterials | Drug Regulatory Process; Drug Development; Drug Safety |
| Compounding Quality Center of Excellence | Engage with the Compounding Quality Center of Excellence | Compounding; Drug Development; Drug Regulatory Process; Drug Safety |
| Opioid Use Disorder, New Biosimilar, Black Family Cancer Awareness Week, & more | Biosimilars; Cancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety; Minority Health, Opioids |
| The Role of Artificial Intelligence in Clinical Trial Design and Research with Dr. ElZarrad | Drug Development; Drug Regulatory Process; Drug Safety; Artificial Intelligence |
| Practitioners’ Guide for Improving Oral Anticoagulant Use | Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs |
| 14th Annual Sentinel Initiative Public Workshop | COVID-19; Drug Regulatory Process; Drug Development; Drug Safety |
| 6 Tip-Offs to Rip-Offs: Don't Fall for Health Fraud Scams | Drug Safety; Health Fraud |
| Accelerating Access to Critical Therapies for ALS | Drug Development; Drug Regulatory Process |
| Accelerating Rare disease Cures (ARC) Program | Drug Development; Drug Regulatory Process; Rare Diseases |
| Achieving Data Quality and Integrity in Maximum Containment Laboratories | Drug Development; Drug Regulatory Process; Drug Safety |
| Advancing Generic Drug Development: Translating Science to Approval 2023 | Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs |
| Advancing Regulatory Science at FDA | Drug Development; Drug Regulatory Process |
| Adverse Events Associated with Compounded Drugs from Outsourcing Facilities | Case Study; Compounding; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch |
| Airflow | Compounding; Drug Development; Drug Regulatory Process; Drug Safety |
| Application of Artificial Intelligence and Machine Learning for Precision Medicine | Drug Development; Drug Regulatory Process; Drug Safety; Artificial Intelligence |
| Are you on a biologic medication? What you need to know about biosimilar treatment options | Biosimilars |
| Areas of Customer Need for Outsourcing Facility Products | Compounding; Drug Development; Drug Regulatory Process; Drug Safety |
| Aseptic Process Simulations (Media Fills) | Compounding; Drug Development; Drug Regulatory Process; Drug Safety |
| BeSafeRx: Your Source for Online Pharmacy Information | Drug Safety: Health Fraud |
| Biological Products, Biosimilars Products, and Interchangeable Biosimilar Products | Biosimilars; Drug Regulatory Process; Drug Development |
| Biosimilar and Interchangeable Biologics: More Treatment Choices | Biosimilars |
| Biosimilar Basics | Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs |
| Biosimilar Basics for Patients | Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs |
| Biosimilar Manufacturing and Variation | Biosimilars; Drug Regulatory Process; Drug Development |
| Biosimilar Medications - What Health Care Providers Need to Know | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety |
| Biosimilar Medications - What Patients Need to Know | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety |
| Biosimilar Regulatory Approval Pathway | Biosimilars; Drug Regulatory Process; Drug Development |
| Biosimilares: Lo que los pacientes con diabetes deben saber | Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español |
| Biosimilares: Lo que los pacientes deben saber | Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español |
| Biosimilars 101: A Primer for Your Practice | Biosimilars; Cancer Drugs; Case Study; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women's Health |
| Biosimilars 102: Interchangeability, Extrapolation, and Immunogenicity - A Regulatory Process Primer (medscape.org) | Biosimilars; Drug Regulatory Process; Drug Development |
| Biosimilars Basics Infographic | Biosimilars; Generic Drugs |
| Biosimilars Curriculum Materials for Health Care Degree Programs | Biosimilars; Case Study; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs |
| Biosimilars in the Real World: Perspectives for Staying Within the Scope of Care | Biosimilars; Cancer Drugs; Case Study; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch |
| Biosimilars Level 1: Foundational Concepts | Biosimilars; Case Study Drug Regulatory Process; Drug Development |
| Biosimilars Level 2: Regulatory and Scientific Concepts | Case Study |
| Biosimilars Multimedia Education Materials | Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety |
| Biosimilars Overview for Health Care Professionals | Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety |
| Biosimilars Patient Materials | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety |
| Biosimilars Resources | Biosimilars; Case Study; Drug Regulatory Process; Drug Development |
| Biosimilars Videos | Drug Development; Biosimilars; Drug Regulatory Process |
| Biosimilars: Are they the same quality? | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety |
| Biosimilars: What Patients Need to Know | Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs |
| Biosimilars: What Patients With Diabetes Need To Know | Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs |
| Biosimillars Health Care Provider Materials | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety |
| Bridging Efficacy and Safety to the Obese | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND/Expanded Access; MedWatch; Women's Health |
| Bringing Clinical Research to Patients | Drug Regulatory Process; Drug Development; Drug Safety |
| CDER’s Emerging Drug Safety Technology Meeting Program | Drug Development; Drug Regulatory Process; Drug Safety; Artificial Intelligence |
| Cleanroom In-person Course | Compounding; Drug Regulatory Process; Drug Development |
| Clinical Trial Basics | Drug Regulatory Process; Drug Development; Drug Safety; IND/Expanded Access; Women's Health |
| Clinical Trial Basics with Dr. Robert Temple | Drug Regulatory Process; Drug Development; Drug Safety; IND/Expanded Access; Women's Health |
| Compounding Outsourcing Facilities Annual Study | Compounding; Drug Development; Drug Regulatory Process; Drug Safety |
| Compounding Quality Center of Excellence Annual Conference 2023 | Compounding, COVID-19, Drug Development, Drug Regulatory Process, Drug Safety |
| Compounding Quality Center of Excellence Virtual Conference | Compounding; Drug Development; Drug Regulatory Process; Drug Safety |
| Conceptos ba¡sicos sobre los biosimilares | Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español |
| Conversation on Paxlovid with Dr. John Farley | COVID-19; Drug Regulatory Process; Drug Development; Drug Safety |
| Conversations on Cancer, Black History Month Program: Real Talk: Our Stories as Black Oncologists at the FDA | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety, Minority Health |
| Conversations on Cancer: "What's on the Horizon: Future of Cancer Care" | Cancer Drugs |
| Conversations on Cancer: Bringing Innovation to People Facing Cancer | Cancer Drugs |
| Conversations on Cancer: Cancer Disparities in Appalachia | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| Conversations on Cancer: Cancer Misinformation: Truth or Consequences | Cancer Drugs, Drug Development, Drug Regulatory Process, Drug Safety |
| Conversations on Cancer: How Biotech Built a Blockbuster Cancer Drug | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| Conversations on Cancer: Living with Metastatic Breast Cancer | Cancer Drugs |
| Conversations on Cancer: National Black Family Cancer Awareness Week, Engaging the Generations | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety, Minority Health |
| Conversations on Cancer: Seasons of Change: Oncology Careers | Cancer Drugs |
| Conversations on Cancer: Transforming Patient Lives by Therapeutic and Regulatory Innovations | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| CURE ID, A Tool for Clinicians to Report New Uses of Existing Drugs with Heather Stone and Dr. Marco Schito | Case Study; COVID-19; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch |
| Drug Approval Case Studies | Case Study; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND/Expanded Access |
| 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 Health |
| Drug Shortages with CDR Emily Thakur | COVID-19; Drug Development; Drug Regulatory Process; Drug Safety |
| Environmental Monitoring In-person Course | Compounding; Drug Regulatory Process; Drug Development |
| Equity of Voices video series | Case Study; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch |
| Expanded Access with Dr. Jacqueline Corrigan-Curay | Drug Development; Drug Regulatory Process; Drug Safety; IND/Expanded Access |
| FDA 101: An Overview of FDA's Regulatory Review and Research Activities | Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND/Expanded Access; OTC Drug Regulations; Women's Health |
| 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 Process |
| FDA approval of Augtyro (repotrectinib) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Epkinly (epcoritamab-bysp) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Fruzaqla (fruquintinib) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Jemperli (dostarlimab-gxly) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Keytruda (pembrolizumab) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Lynparza (Olaparib) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of OGSIVEO (nirogacestat) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Omisirge (omidubicel-onlv) | Cancer Drugs, Drug Development, Drug Regulatory Process, Drug Safety |
| FDA approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Polivy (polatuzumab vedotin-piiq) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients with low-grade glioma with a BRAF V600E mutation | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Tibsovo (ivosidenib) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Trodelvy (sacituzumab govitecan-hziy) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Women's Health |
| FDA approval of Verzenio (abemaciclib) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Women's Health |
| FDA approval of Zynyz (retifanlimab-dlwr) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approvals of Jaypirca (pirtobrutinib) and Orserdu (elacestrant) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Women's Health |
| FDA approvals of Talvey and Elrexfio | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approvals of Tukysa (tucatinib) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA D.I.S.C.O. Burst Edition: Retevmo (selpercatinib) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA Drug Info Rounds | Drug Safety; MedWatch; IND/Expanded Access; Drug Development; Drug Regulatory Process; Generic Drugs |
| FDA Drug Safety Podcasts | Drug Safety |
| FDA Grand Rounds | COVID-19; Drug Regulatory Process; Drug Development; Drug Safety; MedWatch; Generic Drugs; OTC Drug Regulations; Biosimilars; IND/Expanded Access; Cancer Drugs; Women's Health |
| FDA Health Playbook | Drug Safety; OTC Drug Regulations; MedWatch; Opioids |
| FDA Insight | Compounding; COVID-19; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Opioids; Women's Health; OTC Drug Regulations |
| FDA MedWatch and Patient Safety | MedWatch; Drug Safety |
| 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 Indications | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; IND/Expanded Access |
| FDA Overview of Biosimilar Products | Biosimilars;Drug Regulatory Process; Drug Development |
| FDA Rare Disease Day 2023 | Drug Development; Drug Regulatory Process; Drug Safety; Rare Diseases |
| FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds | Drug Development; Drug Regulatory Process; Drug Safety; IND/Expanded Access; Cannabidiol |
| FDA Review and Approval Process for Biosimilar Medications | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety |
| FDA takes steps to decrease barriers for overdose reversal agents with Dr. Marta Sokolowska | Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; OTC Drug Regulations |
| FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use | Drug Regulatory Process; Drug Safety; Opioids |
| FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions | Drug Regulatory Process; Drug Development; Drug Safety |
| 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 Safety |
| 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 Factors | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA's Biomarker Qualification Program | Drug Development |
| FDA's Overdose Prevention Framework with Dr. Marta Sokolowska | Drug Regulatory Process; Drug Development; Drug Safety; MedWatch; Opioids; Cancer Drugs |
| FDA's Regulation of Dietary Supplements with Dr. Cara Welch | Drug Development; Drug Regulatory Process; Drug Safety |
| FDA's Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond | Drug Regulatory Process |
| FDA's Work to Combat the COVID-19 Pandemic | COVID-19; Drug Development; Drug Regulatory Process; Drug Safety |
| GDUFA II Videos and Resources | Drug Development; Generic Drugs |
| Generics and Biosimilars | Biosimilars; Drug Regulatory Process; Drug Development; Generic Drugs |
| Generics-at-a-Glance with Dr. Sarah Ibrahim | Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs |
| Health Equity Forum Podcast | COVID-19; Drug Development; Drug Regulatory Process; Drug Safety; Women's Health |
| Health Fraud Product Database | Drug Safety; Health Fraud |
| Health Fraud Scams | Drug Safety: Health Fraud |
| How FDA and ISMP Utilize Medication Error Reports to Improve Drug Safety | Drug Regulatory Process; Drug Safety |
| How to Use the Consumer Complaint System and MedWatch | Drug Safety; MedWatch |
| Hyperemesis Gravidarum: New Research and Insights | Women's Health; Drug Safety |
| Incorporating Biosimilars Into the Management of Patients With Immunological Conditions | Biosimilars; Cancer Drugs; Case Study; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women's Health |
| Increasing the Efficiency of Biosimilar Development Programs | Biosimilars;Drug Regulatory Process; Drug Development |
| Increasing the Efficiency of Biosimilar Development Programs 2023 | Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety |
| Information about Medications for Opioid Use Disorder (MOUD) | Drug Regulatory Process; Drug Safety; Opioids |
| Insanitary Conditions and Sterility Assurance | Compounding; Drug Development; Drug Regulatory Process; Drug Safety |
| Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products | Development; Drug Regulatory Process; Drug Safety; Generic Drugs |
| Interchangeable Biological Products | Biosimilars |
| Interchangeable Biosimilars | Biosimilars |
| Investigations and Corrective and Preventive Actions (CAPA) 2023 | Compounding; Drug Development; Drug Regulatory Process; Drug Safety |
| Investigations and Corrective and Preventive Actions (CAPA) Virtual Course 2024 | Compounding; Drug Regulatory Process; Drug Development |
| Joint US FDA - Health Canada ICH Public Meeting | Drug Development; Drug Regulatory Process; Drug Safety; IND/Expanded Access |
| Leveraging Health Literacy and Patient Preferences to Reduce Hypoglycemia Events in Patients with Type 2 Diabetes | Drug Safety |
| Maximizing Benefits and Minimizing Harms from Antibiotics | Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch |
| Medical Extended Reality: Applications and Challenges | Drug Regulatory Process; Drug Development; Drug Safety |
| Medication Health Fraud and Avoiding Medication Scams with Cynthia Ng | Drug Safety; MedWatch; Generic Drugs; Drug Regulatory Process, Health Fraud |
| MedWatch, Your Report Can Make a Difference with Dr. Gerald Dal Pan | Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch |
| Minority Health and Health Equity Webinars | Drug Development; Drug Regulatory Process; Drug Safety, Minority Health |
| Navigating the World of Online Pharmacies with CDR Lysette Deshields | Drug Regulatory Process; Drug Safety; Health Fraud |
| OMHHE Health Equity Forum Podcast - Toward Improving Race and Ethnicity Data in Healthcare | Drug Development; Drug Regulatory Process |
| Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch; Opioids; Women's Health |
| Outsourcing Facility Guide | Compounding; Drug Development; Drug Regulatory Process; Drug Safety |
| Overcoming Reluctance and Enhancing Biosimilar Adoption | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety |
| Overcoming Reluctance and Enhancing Biosimilar Adoption (Medscape) | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety |
| Overview of Expanded Access (EA) Program and EA eRequest Site | IND/Expanded Access; Rare Diseases; Drug Regulatory Process; Drug Development; Drug Safety |
| Overview of FDA role regulating and approving drugs | Drug Development; Drug Regulatory Process; Drug Safety; MedWatch |
| PCOS Revisited: Diagnosis, Management, and Future Needs | Women's Health; Drug Safety |
| Personnel Gowning in Sterile Drug Production | Compounding; Drug Development; Drug Regulatory Process; Drug Safety |
| Pregnancy and Lactation Medication Information for the Healthcare Provider | Women's Health; Drug Regulatory Process; Drug Safety |
| Prescribe with Confidence | Drug Regulatory Process; Drug Safety; Opioids |
| Primary Care Providers Can Prescribe with Confidence | Drug Regulatory Process; Drug Safety; Opioids |
| Process Validation Virtual Course | Compounding; Drug Regulatory Process; Drug Development |
| Public meeting: FDA Rare Disease Day 2024 | Drug Regulatory Process; Drug Safety Rare Diseases |
| Putting the Patient into Perspective: Strategies for Educating Patients about Biosimilars | Biosimilars; Cancer Drugs; Case Study; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women's Health |
| Q&A with FDA Podcast | COVID-19; Drug Regulatory Process; Drug Development; Drug Safety; MedWatch |
| Quality Management Systems Virtual Course | Compounding; Drug Regulatory Process; Drug Development |
| READDI for the next pandemic | Drug Development; Drug Regulatory Process; Drug Safety |
| Regulatory Science at CDER Videos | Drug Regulatory Process; Drug Development |
| Reporting Unlawful Sales of Medical Products on the Internet | Drug Safety |
| Risk Evaluation and Mitigation Strategies (REMS) Program Part 1 | Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs |
| Risk Evaluation and Mitigation Strategies (REMS) Program Part 2 | Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs |
| Safe Opioid Disposal | Drug Regulatory Process; Drug Development; Drug Safety; MedWatch; Generic Drugs; Cancer Drugs;Opioids |
| Safety Labeling Changes for Leukotriene Receptor Antagonists and Decisions Behind a Boxed Warning | Drug Regulatory Process; Drug Development; Drug Safety; MedWatch |
| SBIA Chronicles | Drug Regulatory Process |
| Second Annual FDA ASCO WORKSHOP on Getting the Dosage Right | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| Stability and Beyond Use Dates | Case Study; Compounding; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch; Case Study |
| State of Outsourcing Facility Sector and Possibilities for the Future | Compounding; Drug Development; Drug Regulatory Process; Drug Safety |
| A Step Forward in the Treatment of Opioid and Alcohol Dependence with Dr. Iilun Murphy and Dr. Marta Sokolowska | Drug Regulatory Process; Drug Safety; Generic Drugs; Opioids |
| Sterile Drug Compounding In-person Course | Compounding; Drug Regulatory Process; Drug Development |
| Sterility Testing: Common Misconceptions | Compounding; Drug Development; Drug Regulatory Process; Drug Safety |
| Successes and Opportunities in Modeling and Simulation for FDA | Drug Development; Drug Regulatory Process |
| Summary Report for Biosimilars | Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety |
| Supplier/Contractor Qualification and Management | Compounding; Drug Development; Drug Regulatory Process; Drug Safety |
| Switching Between Biosimilars and Their Reference Counterparts with Dr. Sarah Yim | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety |
| The Current Status of Oral Phenylephrine as a Nasal Decongestant with Dr. Theresa Michele and Dr. Ilisa Bernstein | Drug Regulatory Process; Drug Safety; OTC Drug Regulations |
| The FDA Bad Ad Program and Prescription Drug Promotion | Drug Regulatory Process; Drug Safety |
| The FDA Process for Approving Generic Drugs | Drug Regulatory Process; Drug Development; Generic Drugs |
| The Future of Clinical Trials, The Real Cost Campaign, and Sun Safety Tips | Drug Development; Drug Regulatory Process; Drug Safety; Suncreen |
| The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development | Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety |
| Topics in Public Health | Biosimilars; 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 Health |
| Treatment Using Medication for Opioid Use Disorder Can Save Lives | Drug Regulatory Process; Drug Safety; Opioids |
| 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 obesity | Drug Regulatory Process; Drug Development; Drug Safety |
| 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 obesity | Drug Development; Drug Regulatory Process; Drug Safety; MedWatch |
| Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products | Drug Development; Drug Regulatory Process; Drug Safety |
| What does FDA regulate? | Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; OTC Drug Regulations; Women's Health |
| What is a Biosimilar? | Biosimilars; Drug Regulatory Process; Drug Development |
| What is a Biosimilar? (Spanish) | Biosimilars; Drug Regulatory Process; Drug Development; Español |
| Where and How to Dispose of Unused Medicines | Drug Safety; Opioids |
| Why Does the FDA Exist? | Drug Development; Drug Regulatory Process; Drug Safety |
| FDA Drug Topics Webinars | Biosimilars; Cancer Drugs; Cannabidiol; Compounding; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Health Fraud; IND/Expanded Access; Opioids; Rare Diseases |
| FDA approvals of Augtyro (repotrectinib) and Krazati (adagrasib) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| Real-World Data and Evidence Generation with Dr. Hilary Marston | Drug Development; Drug Regulatory Process; Drug Safety; Artificial Intelligence |
| Medicamentos biosimilares: Lo que los pacientes deben saber | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety |
| What is Accelerated Approval? | Cancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety |
| How are Cancer Drugs Approved? | Cancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety |
| FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause | Women's Health; Drug Safety |
| Curriculum Materials for Health Care Degree Programs | Biosimilars | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety |
| FDA’s Role In Managing Drug Shortages | Drug Regulatory Process; Drug Safety |
| Sepa cuándo y cómo usar antibióticos | Drug Regulatory Process; Drug Safety; Español |
| OCE Conversations on Cancer, Cervical Cancer Treatment Innovation: A Collaborative Discussion | Cancer Drugs; Drug Development; Women's Health |
| FDA approval of Ryoncil (remestemcel-L-rknd) | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
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