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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Upcoming CE Events
- FDA Drug Topics: Fraudulent Drugs: You’re Using What? - May 21, 2024
- OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice - June 13, 2024
- OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration - June 18, 2024
Description | Topic | CE | Credits |
---|---|---|---|
14th Annual Sentinel Initiative Public Workshop | COVID-19; Drug Regulatory Process; Drug Development; Drug Safety | No | 0 |
2024 Compounding Quality Center of Excellence Annual Conference | Compounding; Drug Development; Drug Regulatory Process; Drug Safety | Yes | 3 |
6 Tip-Offs to Rip-Offs: Don't Fall for Health Fraud Scams | Drug Safety; Health Fraud | No | 0 |
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 Transparency and Regulatory Science Activities on the Risk Evaluation and Mitigation Strategy (REMS) | Drug Regulatory Process; Drug Development; Drug Safety | Yes | 1 |
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 |
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 |
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 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 Drug Topics: The Ins and Outs of Prescription Drug Labeling | Drug Regulatory Process; Drug Development; Drug Safety | Yes | 1 |
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 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 | Yes | 0.5 |
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 | ||
Overcoming Reluctance and Enhancing Biosimilar Adoption (Medscape) | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety | Yes | 0.5 |
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 |
An Overview of FDA’s Project Facilitate Oncology Expanded Access Program | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process | Yes | 1 |
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 |
Public meeting: FDA Rare Disease Day 2024 | Drug Regulatory Process; Drug Safety Rare Diseases | Yes | 4.75 |
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 |
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 |
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 |
Switching Between Biosimilars and Their Reference Counterparts with Dr. Sarah Yim | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety | Yes | 0.5 |
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 | Yes | 0.5 |
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 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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