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
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Introduction to the Drug Master File (DMF) Review Process

FDA Safety Report Type Flag Requirement for FAERS Submissions
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FDA Safety Report Type Flag Requirement for FAERS Submissions

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

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

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

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

Advancing Real-Time Clinical Trials
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Advancing Real-Time Clinical Trials

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

OTC Monograph Reform: OTC Sunscreen Drugs
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OTC Monograph Reform: OTC Sunscreen Drugs

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

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

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

FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers
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FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers

AGDD 2025 | D2S05 - Workshop Closing Remarks
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AGDD 2025 | D2S05 - Workshop Closing Remarks

Understanding the Nutrition Facts Label, the Updated “Healthy” Claim, and Other Nutrition Claims
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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
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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
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Drug Master File (DMF) Submissions on New FDA Form 3938

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

VRBPAC -- May 28 Meeting
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VRBPAC -- May 28 Meeting

AGDD 2025 | D1S00 - Welcome and Opening Remarks
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AGDD 2025 | D1S00 - Welcome and Opening Remarks