CDERLearn: Enhancing Knowledge and Skills with Innovative Educational Approaches

CDERLearn: Enhancing Knowledge and Skills with Innovative Educational Approaches

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Understanding Drug Recalls with Dr. Ileana Elder
Drug Regulatory Process; Drug Safety No 0
Resource Guide for Teaching Faculty
Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety No 0
Utilizing Generic Drug Awareness to Improve Patient Outcomes with Dr. Sarah Ibrahim
Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs No 0
FDA D.I.S.C.O. Burst Edition: FDA approval of Retevmo
Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
Accidental Exposures to Fentanyl Patches Continue to Be Deadly to Children
Drug Regulatory Process; Drug Safety; Opioids No 0
Should You Give Kids Medicine for Coughs and Colds?
Drug Regulatory Process; Drug Safety; OTC Drug Regulations No 0
What Does FDA Approve? Part 2
Drug Safety; MedWatch No 0
Is It Really ‘FDA Approved’?
Compounding; Drug Development; Drug Regulatory Process; Drug Safety No 0
10 Facts about What FDA Does and Does Not Approve
CBD; Compounding; Drug Development; Drug Regulatory Process; Drug Safety No 0
Sunscreen: How to Help Protect Your Skin from the Sun
Sunscreen No 0
Facts about Sunscreen
Sunscreen No 0
Medicamentos
Drug Development; Drug Regulatory Process; Drug Safety; Español No 0
Datos acerca de los medicamentos genéricos
Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español No 0
Hechos Sobre Los Medicamentos Genericos
Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español No 0
Medicamentos Genéricos: Preguntas y Respuestas
Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español No 0
2024 PDA/ FDA Joint Regulatory Conference
Drug Development; Drug Regulatory Process; Drug Safety No 0
Complex Innovative Trial Design Meeting Program
Case Study; Drug Development; Drug Regulatory Process; Drug Safety No 0
FDA approval of Ojemda (tovorafenib)
Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0
Conversations on Cancer—Strength in Numbers: Increasing Cancer Awareness While Decreasing Disparities
Cancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety; Minority Health No 0
Conversations on Cancer: ODAC Chronicles – the Past, Present, and Future of Oncology Advisory Committees
Cancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety No 0
Considerations for Drug Products that Contain Nanomaterials
Drug Regulatory Process; Drug Development; Drug Safety No 0
Compounding Quality Center of Excellence | Engage with the Compounding Quality Center of Excellence
Compounding; Drug Development; Drug Regulatory Process; Drug Safety No 0
Opioid Use Disorder, New Biosimilar, Black Family Cancer Awareness Week, & more
Biosimilars; Cancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety; Minority Health, Opioids No 0
The Role of Artificial Intelligence in Clinical Trial Design and Research with Dr. ElZarrad
Drug Development; Drug Regulatory Process; Drug Safety; Artificial Intelligence Yes 0.5
Practitioners’ Guide for Improving Oral Anticoagulant Use
Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0
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 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
Training Course: 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
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; Artificial Intelligence 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
Biosimilars: Lo que los pacientes con diabetes deben saber
Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español No 0
Biosimilars: Lo que los pacientes deben saber
Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español 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
Biosimilars 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; Cannabidiol 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
CDER’s Emerging Drug Safety Technology Meeting Program
Drug Development; Drug Regulatory Process; Drug Safety; Artificial Intelligence 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 Yes 0.5
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; Español No 0 Conversation on Paxlovid with Dr. John Farley COVID-19; Drug Regulatory Process; Drug Development; Drug Safety Yes 0.5
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 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 Cancer Drugs 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 Cancer Drugs No 0 Conversations on Cancer: National Black Family Cancer Awareness Week, Engaging the Generations Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety, Minority Health 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 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 D.I.S.C.O. Burst Edition: Retevmo (selpercatinib)
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