Keynote from Director Lawrence Yu - Drug Master File (DMF) and Drug Substance Workshop
Director of the Office of New Drug Products (ONDP) Lawrence Yu, Ph.D. in the Office of Pharmaceutical Quality welcomes participants to the Drug Master File (DMF) and Drug Substance Workshop. He provides an overview of past quality issues and current initiatives. Learn more at: https://www.fda.gov/drugs/news-events... -------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2021 Playlist - • 2021 CDER Small Business and Industry Assi... SBIA LinkedIn: / cder-small-business-and-industry-assistance SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter - / fda_drug_info Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367

Introduction to the Drug Master File (DMF) Review Process

FDA Safety Report Type Flag Requirement for FAERS Submissions

AGDD 2025 | D2S03 - Common Deficiencies and Resolutions: Complex Drug Substance/Excipients/Products

CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products

AGDD 2025 | D2S04 - Nitrosamines: Known Issues and Practical Advice

Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing

Advancing Real-Time Clinical Trials

FDA Direct: Faster Reviews, Food Dye Wins and Protecting American DNA

OTC Monograph Reform: OTC Sunscreen Drugs

Major Issues and Facilities in Drug Master Files (9/15) Global Quality

FDA Grand Rounds - Pharmacovigilance in Practice: From Safety Signals to Regulatory Action

CDER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products

FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers

AGDD 2025 | D2S05 - Workshop Closing Remarks

Understanding the Nutrition Facts Label, the Updated “Healthy” Claim, and Other Nutrition Claims

OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products

Drug Master File (DMF) Submissions on New FDA Form 3938

ClinicalTrials.gov: Essentials for Academic Medical Centers – Pre-recorded Training Video

VRBPAC -- May 28 Meeting

