CDER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities Chapters: Plenary Session - 05:32 Clinical Trial Innovation: From Policy to Practice - Meghana Chalasani - 2:14:05 From Framework to Approval: Operationalizing FDA's Real World Evidence Program in Regulatory Decision Making - Motiur Rahman - 02:52:02 Quality Assurance Through CGMP: Understanding FDA Drug Manufacturing Inspections - Anastasia Shields - 04:32:03 ICH E6(R3): Achieving Quality Through Purpose-Driven Clinical Trials - Cheryl Grandinetti - 05:11:30 The Use of AI to Advance Drug Development - Anindita (Annie) Saha - 06:07:19 FDA CDER Emerging Drug Safety Technology Program - Oanh Dang - 06:43:31
CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
CDER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing
CDER & CBER All Hands: Implementing the FDA's Plausible Mechanism Framework
VRBPAC -- May 28 Meeting
FDA Direct - Special Edition of FDA Direct
Advancing Real-Time Clinical Trials
FDA Grand Rounds - Clinical Omics Biomarker Discovery and Validation in Precision Medicine
OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products
CBER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
FDA Direct: Combating Rare Diseases at the FDA
April 30, 2026 Meeting of the Oncologic Drugs Advisory Committee (ODAC)
FDA Direct: The Power of Real-Time Clinical Trials
FDA Direct: What's the Deal with Talc? - Recapping
Understanding the Nutrition Facts Label, the Updated “Healthy” Claim, and Other Nutrition Claims
FDA Direct: Citrus Regs, Natural Dye Pledges, and Hidden Opioids
CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
FDA Direct: Who Buys the Spin — Hook, Line and Sinker?
ClinicalTrials.gov: Essentials for Academic Medical Centers – Pre-recorded Training Video
