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CDERLearn

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

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Description Topic CE Credits
14th Annual Sentinel Initiative Public Workshop COVID-19; Drug Regulatory Process; Drug Development; Drug Safety No 0
6 Tip-Offs to Rip-Offs: Don't Fall for Health Fraud Scams Drug Safety; Health Fraud No 0
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 Yes 0.5
Accelerating Access to Critical Therapies for ALS Drug Development; Drug Regulatory Process No 0
Accelerating Rare disease Cures (ARC) Program Drug Development; Drug Regulatory Process; Rare Diseases No 0
Achieving Data Quality and Integrity in Maximum Containment Laboratories Drug Development; Drug Regulatory Process; Drug Safety No 0
Advancing Generic Drug Development: Translating Science to Approval 2023 Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0
Advancing Regulatory Science at FDA Drug Development; Drug Regulatory Process No 0
Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice Case Study; Drug Development; Drug Regulatory Process; Drug Safety No 0
Advancing Transparency and Regulatory Science Activites on the Risk Evaluation and Mitigation Strategy (REMS) Drug Regulatory Process; Drug Development; Drug Safety Yes 1
Adverse Events Associated with Compounded Drugs from Outsourcing Facilities Case Study; Compounding; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch No 0
Airflow Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 4
An Overview of FDA’s Project Facilitate Oncology Expanded Access Program Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process Yes 1
Application of Artificial Intelligence and Machine Learning for Precision Medicine Drug Development; Drug Regulatory Process; Drug Safety No 0
Are you on a biologic medication? What you need to know about biosimilar treatment options Biosimilars No 0
Areas of Customer Need for Outsourcing Facility Products Compounding; Drug Development; Drug Regulatory Process; Drug Safety No 0
Aseptic Process Simulations (Media Fills) Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 2
Bench to Bedside: Integrating Sex and Gender to Improve Human Health Drug Development; Drug Regulatory Process; Drug Safety; Women's Health Yes 1
BeSafeRx: Your Source for Online Pharmacy Information Drug Safety: Health Fraud No 0
Biological Products, Biosimilars Products, and Interchangeable Biosimilar Products Biosimilars; Drug Regulatory Process; Drug Development No 0
Biosimilar and Interchangeable Biologics: More Treatment Choices Biosimilars No 0
Biosimilar and Interchangeable Biosimilars: Review of Scientific Concepts, Case Studies, and Resources Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety Yes 1
Biosimilar Basics Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0
Biosimilar Basics for Patients Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0
Biosimilar Manufacturing and Variation Biosimilars; Drug Regulatory Process; Drug Development No 0
Biosimilar Medications - What Health Care Providers Need to Know Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety No 0
Biosimilar Medications - What Patients Need to Know Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety No 0
Biosimilar Regulatory Approval Pathway Biosimilars; Drug Regulatory Process; Drug Development No 0
Biosimilares: Lo que los pacientes con diabetes deben saber Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0
Biosimilares: Lo que los pacientes deben saber Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0
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 Yes 0.25
Biosimilars 102: Interchangeability, Extrapolation, and Immunogenicity - A Regulatory Process Primer (medscape.org) Biosimilars; Drug Regulatory Process; Drug Development Yes 0.25
Biosimilars Basics Infographic Biosimilars; Generic Drugs No 0
Biosimilars Curriculum Materials for Health Care Degree Programs Biosimilars; Case Study; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0
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 Yes 0.5
Biosimilars Level 1: Foundational Concepts Biosimilars; Case Study Drug Regulatory Process; Drug Development No 0
Biosimilars Level 2: Regulatory and Scientific Concepts Case Study No 0
Biosimilars Multimedia Education Materials Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety No 0
Biosimilars Overview for Health Care Professionals Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety No 0
Biosimilars Patient Materials Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety No 0
Biosimilars Resources Biosimilars; Case Study; Drug Regulatory Process; Drug Development No 0
Biosimilars Videos Drug Development; Biosimilars;  Drug Regulatory Process No 0
Biosimilars: A Review of Scientific, Regulatory, and Clinical Considerations for Health Care Providers Biosimilars; Drug Regulatory Process; Drug Development Yes 1
Biosimilars: Are they the same quality? Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety No 0
Biosimilars: What Patients Need to Know Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0
Biosimilars: What Patients With Diabetes Need To Know Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0
Biosimillars Health Care Provider Materials Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety No 0
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 No 0
Bringing Clinical Research to Patients  Drug Regulatory Process; Drug Development; Drug Safety Yes 1
Cannabis and Cannabis-Derived Products – For Healthcare Practitioners Drug Regulatory Process; Drug Development; Drug Safety Yes 1
CDER Conversation: Improving Medication Adherence and Patient Experience by Researching Patient Perceptions of Generic Drug Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0
CDER Webinars Drug Regulatory Process; Drug Development; Generic Drugs; OTC Drug Regulations; Biosimilars; Drug Safety; MedWatch; IND/Expanded Access; Cancer Drugs No 0
Cleanroom In-person Course Compounding; Drug Regulatory Process; Drug Development Yes 13.75
Clinical Trial Basics Drug Regulatory Process; Drug Development; Drug Safety; IND/Expanded Access; Women's Health No 0
Clinical Trial Basics with Dr. Robert Temple Drug Regulatory Process; Drug Development; Drug Safety; IND/Expanded Access; Women's Health No 0
Compounding Outsourcing Facilities Annual Study Compounding; Drug Development; Drug Regulatory Process; Drug Safety No 0
Compounding Quality Center of Excellence Annual Conference 2023 Compounding, COVID-19, Drug Development, Drug Regulatory Process, Drug Safety No 0
Compounding Quality Center of Excellence Virtual Conference Compounding; Drug Development; Drug Regulatory Process; Drug Safety No 0
Conceptos ba¡sicos sobre los biosimilares Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0
Conversation on Paxlovid with Dr. John Farley COVID-19; Drug Regulatory Process; Drug Development; Drug Safety No 0
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 No 0
Conversations on Cancer: "What's on the Horizon: Future of Cancer Care" Cancer Drugs No 0
Conversations on Cancer: Bringing Innovation to People Facing Cancer   No 0
Conversations on Cancer: Cancer Disparities in Appalachia Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
Conversations on Cancer: Cancer Misinformation: Truth or Consequences Cancer Drugs, Drug Development, Drug Regulatory Process, Drug Safety No 0
Conversations on Cancer: How Biotech Built a Blockbuster Cancer Drug Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
Conversations on Cancer: Living with Metastatic Breast Cancer   No 0
Conversations on Cancer: National Black Family Cancer Awareness Week, Engaging the Generations Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
Conversations on Cancer: Seasons of Change: Oncology Careers Cancer Drugs No 0
Conversations on Cancer: Transforming Patient Lives by Therapeutic and Regulatory Innovations Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
Counseling Patients on Generic Drugs Generic Drugs; Drug Regulatory Process; Drug Development; Drug Safety Yes 1
C-Path Scientific Breakthrough Summit 2023 Drug Development; Drug Regulatory Process; Drug Safety No 0
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 Yes 0.5
Development and U.S. Regulation of Preventative Vaccines Drug Regulatory Process; Drug Development Yes 1
Drug Approval Case Studies Case Study; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND/Expanded Access No 0
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 No 0
Drug Shortages with CDR Emily Thakur COVID-19; Drug Development; Drug Regulatory Process; Drug Safety Yes 0.5
Drug Shortages: Root Causes and Potential Solutions Drug Regulatory Process; Drug Development Yes 1
Engaging Providers to Address Knowledge Gaps on Medication Use in Pregnancy and Lactation Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch; Women's Health Yes 1
Enhanced Drug Distribution Security: 2023 and Beyond Drug Regulatory Process; Drug Safety Yes 1
Environmental Monitoring In-person Course Compounding; Drug Regulatory Process; Drug Development Yes 15.25
Equity of Voices video series Case Study; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch No 0
Expanded Access with Dr. Jacqueline Corrigan-Curay Drug Development; Drug Regulatory Process; Drug Safety; IND/Expanded Access Yes 0.5
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 No 0
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 Yes 0.5
FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab) Drug Development; Drug Regulatory Process; Drug Safety; MedWatch No 0
FDA approval of Augtyro (repotrectinib) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
FDA approval of Epkinly (epcoritamab-bysp) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
FDA approval of Fruzaqla (fruquintinib) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
FDA approval of Jemperli (dostarlimab-gxly) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
FDA approval of Keytruda (pembrolizumab) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
FDA approval of Lynparza (Olaparib) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
FDA approval of OGSIVEO (nirogacestat) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
FDA approval of Omisirge (omidubicel-onlv) Cancer Drugs, Drug Development, Drug Regulatory Process, Drug Safety No 0
FDA approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
FDA approval of Polivy (polatuzumab vedotin-piiq) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
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 No 0
FDA approval of Tibsovo (ivosidenib) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
FDA approval of Trodelvy (sacituzumab govitecan-hziy) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Women's Health No 0
FDA approval of Verzenio (abemaciclib) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Women's Health No 0
FDA approval of Zynyz (retifanlimab-dlwr) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
FDA approvals of Jaypirca (pirtobrutinib) and Orserdu (elacestrant) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Women's Health No 0
FDA approvals of Talvey and Elrexfio Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
FDA approvals of Tukysa (tucatinib) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
FDA Drug Info Rounds Drug Safety; MedWatch; IND/Expanded Access; Drug Development; Drug Regulatory Process; Generic Drugs No 0
FDA Drug Information Resources and Applicability to Health Care Professionals Drug Regulatory Process; Drug Development; Drug Safety; MedWatch Yes 1
FDA Drug Safety Podcasts Drug Safety No 0
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 No 0
FDA Health Playbook Drug Safety; OTC Drug Regulations; MedWatch; Opioids No 0
FDA Insight Compounding; COVID-19; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Opioids; Women's Health; OTC Drug Regulations No 0
FDA MedWatch and Patient Safety MedWatch; Drug Safety No 0
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 No 0
FDA Overview of Biosimilar Products Biosimilars;Drug Regulatory Process; Drug Development No 0
FDA Rare Disease Day 2023 Drug Development; Drug Regulatory Process; Drug Safety; Rare Diseases No 0
FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds Drug Development; Drug Regulatory Process; Drug Safety; IND/Expanded Access No 0
FDA Review and Approval Process for Biosimilar Medications Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety No 0
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 Yes 0.5
FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use Drug Regulatory Process; Drug Safety; Opioids Yes 0.5
FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use Drug Development; Drug Regulatory Process; Drug Safety; MedWatch; Opioids No 0
FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions Drug Regulatory Process; Drug Development; Drug Safety Yes 0.5
FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions Drug Regulatory Process; Drug Safety; MedWatch No 0
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 Yes 0.5
FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan) Drug Development; Drug Regulatory Process; Drug Safety; MedWatch No 0
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 No 0
FDA’s Office of Orphan Products Development (OOPD) – An Overview and Update Rare Diseases; Drug Regulatory Process; Drug Development; Drug Safety Yes 1
FDA’s Role in Postmarketing Drug Safety Surveillance Drug Regulatory Process; Drug Development; Drug Safety; MedWatch Yes 1
FDA's Biomarker Qualification Program Drug Development No 0
FDA's Overdose Prevention Framework with Dr. Marta Sokolowska Drug Regulatory Process; Drug Development; Drug Safety; MedWatch; Opioids; Cancer Drugs No 0
FDA's Regulation of Dietary Supplements with Dr. Cara Welch Drug Development; Drug Regulatory Process; Drug Safety Yes 0.5
FDA's Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond Drug Regulatory Process No 0
FDA's Work to Combat the COVID-19 Pandemic COVID-19; Drug Development; Drug Regulatory Process; Drug Safety No 0
Fraudulent Products – Hidden Ingredients and Unproven Claims in Products Marketed as Dietary Supplements Drug Regulatory Process; Drug Safety Yes 1
Frequently Asked Questions about Labeling for Prescription Medicines Drug Regulatory Process; Drug Development; Drug Safety Yes 1
GDUFA II Videos and Resources Drug Development; Generic Drugs No 0
Generics and Biosimilars Biosimilars; Drug Regulatory Process; Drug Development; Generic Drugs No 0
Generics-at-a-Glance with Dr. Sarah Ibrahim Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0
Health Equity Forum Podcast COVID-19; Drug Development; Drug Regulatory Process; Drug Safety; Women's Health No 0
Health Fraud Product Database Drug Safety; Health Fraud No 0
Health Fraud Scams Drug Safety: Health Fraud No 0
Highlights in Oncofertility: Trends in an Emerging Field for Cancer Survivors Cancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety; Women's Health No 0
How FDA and ISMP Utilize Medication Error Reports to Improve Drug Safety Drug Regulatory Process; Drug Safety Yes 1
How to Avoid Medication Errors with Pen Injectors Drug Safety; MedWatch Yes 1
How to Use the Consumer Complaint System and MedWatch Drug Safety; MedWatch No 0
Hyperemesis Gravidarum: New Research and Insights Women's Health; Drug Safety Yes 1
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 Yes 1
Increasing the Efficiency of Biosimilar Development Programs Biosimilars;Drug Regulatory Process; Drug Development No 0
Increasing the Efficiency of Biosimilar Development Programs 2023 Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety No 0
Insanitary Conditions and Sterility Assurance Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 4
Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0
Interchangeable Biological Products Biosimilars No 0
Interchangeable Biosimilars Biosimilars No 0
Investigations and Corrective and Preventive Actions (CAPA) 2023 Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 5
Investigations and Corrective and Preventive Actions (CAPA) Virtual Course 2024 Compounding; Drug Regulatory Process; Drug Development No 0
Joint US FDA - Health Canada ICH Public Meeting Drug Development; Drug Regulatory Process; Drug Safety; IND/Expanded Access No 0
Leveraging Health Literacy and Patient Preferences to Reduce Hypoglycemia Events in Patients with Type 2 Diabetes Drug Safety No 0
Leveraging Real-World Data to Study Medication Use in Pregnancy and Lactation Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch; Women's Health No 0
Maximizing Benefits and Minimizing Harms from Antibiotics Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch No 0
Medical Extended Reality: Applications and Challenges Drug Regulatory Process; Drug Development; Drug Safety No 0
Medication Health Fraud and Avoiding Medication Scams with Cynthia Ng Drug Safety; MedWatch; Generic Drugs; Drug Regulatory Process No 0
MedWatch, Your Report Can Make a Difference with Dr. Gerald Dal Pan Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch No 0
Minority Health and Health Equity Webinars Drug Development; Drug Regulatory Process; Drug Safety No 0
Naltrexone Injection for Opioid Use Disorder - FDA's Efforts to Reduce Medication Errors Drug Regulatory Process; Drug Safety; MedWatch; Opioids No 0
Navigating the World of Online Pharmacies with CDR Lysette Deshields Drug Regulatory Process; Drug Safety; Health Fraud Yes 0.5
OMHHE Health Equity Forum Podcast - Toward Improving Race and Ethnicity Data in Healthcare Drug Development; Drug Regulatory Process No 0
Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch; Opioids; Women's Health No 0
Outsourcing Facility Guide Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 1.75
Overcoming Reluctance and Enhancing Biosimilar Adoption     0
Overview of Expanded Access (EA) Program and EA eRequest Site IND/Expanded Access; Rare Diseases; Drug Regulatory Process; Drug Development; Drug Safety Yes 1
Overview of FDA role regulating and approving drugs Drug Development; Drug Regulatory Process; Drug Safety; MedWatch No 0
PCOS Revisited: Diagnosis, Management, and Future Needs  Women's Health; Drug Safety Yes 1
Personnel Gowning in Sterile Drug Production Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 0.5
Pregnancy and Lactation Medication Information for the Healthcare Provider Women's Health; Drug Regulatory Process; Drug Safety Yes 1
Process Validation Virtual Course Compounding; Drug Regulatory Process; Drug Development Yes 15
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 Yes 0.25
Q&A with FDA COVID-19; Drug Regulatory Process; Drug Development; Drug Safety; MedWatch No 0
Quality Management Systems Virtual Course Compounding; Drug Regulatory Process; Drug Development Yes 15
Rare Diseases - Challenges and Progress in Drug Development Drug Development; Drug Safety; Rare Diseases Yes 1
READDI for the next pandemic Drug Development; Drug Regulatory Process; Drug Safety No 0
Regulatory Framework for Human Drug Compounding Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 1.5
Regulatory Science at CDER Videos Drug Regulatory Process; Drug Development No 0
Reporting and Public Viewing of Individual Case Safety Reports (ICSRs) Drug Regulatory Process; Drug Development; Drug Safety; MedWatch Yes 1
Reporting Unlawful Sales of Medical Products on the Internet Drug Safety No 0
Risk Evaluation and Mitigation Strategies (REMS) Program Part 1 Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0
Risk Evaluation and Mitigation Strategies (REMS) Program Part 2 Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0
Safe Opioid Disposal Drug Regulatory Process; Drug Development; Drug Safety; MedWatch; Generic Drugs; Cancer Drugs;Opioids No 0
Safety Labeling Changes for Leukotriene Receptor Antagonists and Decisions Behind a Boxed Warning Drug Regulatory Process; Drug Development; Drug Safety; MedWatch Yes 1
SBIA Chronicles Drug Regulatory Process No 0
Second Annual FDA ASCO WORKSHOP on Getting the Dosage Right Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
Stability and Beyond Use Dates Case Study; Compounding; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch; Case Study Yes 4
State of Outsourcing Facility Sector and Possibilities for the Future Compounding; Drug Development; Drug Regulatory Process; Drug Safety No 0
Sterile Drug Compounding In-person Course Compounding; Drug Regulatory Process; Drug Development Yes 16
Sterility Testing: Common Misconceptions Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 0.75
Successes and Opportunities in Modeling and Simulation for FDA Drug Development; Drug Regulatory Process No 0
Successfully Navigating the USPTO and FDA Drug Development; Drug Regulatory Process; Drug Safety No 0
Summary Report for Biosimilars Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety No 0
Supplier/Contractor Qualification and Management Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 4
The Current Status of Oral Phenylephrine as a Nasal Decongestant with Dr. Theresa Michele and Dr. Ilisa Bernstein     0
The FDA Bad Ad Program and Prescription Drug Promotion Drug Regulatory Process; Drug Safety No 0
The FDA Process for Approving Generic Drugs Drug Regulatory Process; Drug Development; Generic Drugs No 0
The History of FDA Drug Development; Drug Regulatory Process; Drug Safety No 0
The Ins and Outs of Prescription Drug Labeling Drug Regulatory Process; Drug Development; Drug Safety Yes 1
The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety No 0
The Safety Evaluation and Surveillance of Generic Drugs Generic Drugs; Drug Regulatory Process; Drug Development; Drug Safety Yes 1.5
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 Yes 1
Understanding Generic Narrow Therapeutic Index Drugs Generic Drugs; Drug Regulatory Process; Drug Development; Drug Safety Yes 1
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 Yes 0.5
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 obesity Drug Development; Drug Regulatory Process; Drug Safety; MedWatch No 0
Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products Drug Development; Drug Regulatory Process; Drug Safety No 0
What does FDA regulate? Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; OTC Drug Regulations; Women's Health No 0
What is a Biosimilar? Biosimilars; Drug Regulatory Process; Drug Development No 0
What is a Biosimilar? (Spanish) Biosimilars; Drug Regulatory Process; Drug Development No 0
Why Does the FDA Exist? Drug Development; Drug Regulatory Process; Drug Safety No 0

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