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Center for Drug Evaluation and Research (CDER) CDERLearn Training

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2026/04/22

Center for Drug Evaluation and Research (CDER) CDERLearn Training

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Continuing Education (CE) Credits Update

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Topic Artificial IntelligenceBiosimilarsCancer DrugsCannabidiolCompoundingCOVID-19Drug DevelopmentDrug Regulatory ProcessDrug SafetyEspañolGeneric DrugsHealth FraudIND/Expanded AccessMedWatchMinority HealthOpioidsOTC Drug RegulationsRare DiseasesSunscreenWomen's Health

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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

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

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

Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety

Biosimilar Regulatory Approval Pathway

Biosimilars; Drug Regulatory Process; Drug Development

Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español

Biosimilars; Cancer Drugs; Case Study; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women's Health

Biosimilars; Drug Regulatory Process; Drug Development

Biosimilars Basics Infographic

Biosimilars; Generic Drugs

Biosimilars; Case Study; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs

Biosimilars; Cancer Drugs; Case Study; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch

Biosimilars; Case Study Drug Regulatory Process; Drug Development

Case Study

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

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

Interchangeable Biological Products

Biosimilars

Interchangeable Biosimilars

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

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