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: 07:12 - Advanced Drug Manufacturing in CDER, Adam Fisher 55:36 - FDA PreCheck (A CDER perspective), Cyrus Agarabi 01:52:53 - FDA Electronic Submission Update 1) Updates to eCTD for v3.2.2 and v4.0; 2) FDA Information Request (IR) Modernization Proof of Concept; 3) FDA CDER NextGen Portal, Heather Crandall, Jonathan Resnick, Seyoum Senay 02:31:46 - Verifying Data Reliability: Observations on Bioavailability/Bioequivalence and Good Laboratory Practice Studies supporting the Development of New and Generic Drugs and Therapeutic Biologics, Sean Y. Kassim 04:13:15 - Clinical Trial Innovation: Reducing Regulatory Uncertainty, Emily S. Gebbia 04:52:19 - Approaches for Streamlining the Nonclinical Safety Assessment for CDER-Regulated Products, Jessica Bonzo 05:46:57 - Update on Rare Diseases at CDER, Scott Winiecki
CBER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing
VRBPAC -- May 28 Meeting
CDER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
Advancing Real-Time Clinical Trials
OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products
FDA Direct - Special Edition of FDA Direct
FDA Grand Rounds - Clinical Omics Biomarker Discovery and Validation in Precision Medicine
ClinicalTrials.gov: Essentials for Academic Medical Centers – Pre-recorded Training Video
FDA Direct: Combating Rare Diseases at the FDA
CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
FDA Direct: The Power of Real-Time Clinical Trials
CDER & CBER All Hands: Implementing the FDA's Plausible Mechanism Framework
April 30, 2026 Meeting of the Oncologic Drugs Advisory Committee (ODAC)
FDA Direct: No One Think It's a Good Idea for Kids to Consume Petroleum Products
Understanding the Nutrition Facts Label, the Updated “Healthy” Claim, and Other Nutrition Claims
CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
FDA Direct: Who Buys the Spin — Hook, Line and Sinker?
FDA Direct: An Eye on CDRH: Regulating for a New Era of Medical Devices
