Introduction to the Drug Master File (DMF) Review Process
Erin Skoda from the Office of Pharmaceutical Quality, Division of Lifecycle API, discusses the Drug Master File review process from a timeline perspective with an emphasis on key points to be covered during the workshop. 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
Administrative Aspects of Managing a Drug Master File (DMF)
Process Validation and ICH Q7
Risk Basics for Medical Devices
CMC Considerations for CAR T Cell Product Development
Keynote from Director Lawrence Yu - Drug Master File (DMF) and Drug Substance Workshop
Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing
ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues
Advancing Real-Time Clinical Trials
Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020
AGDD 2025 | D2S03 - Common Deficiencies and Resolutions: Complex Drug Substance/Excipients/Products
Planning for Co-development of Companion Diagnostics
Overview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA - REdI 2020
OTC Monograph Reform: OTC Sunscreen Drugs
Drug Master File (DMF) Submissions on New FDA Form 3938
FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers
CMC Considerations for Biotechnology Product Development: A Regulatory Perspective
AGDD 2025 | D1S02 - Novel Bioequivalence Study Design Recommendations
FDA Grand Rounds - Clinical Omics Biomarker Discovery and Validation in Precision Medicine
FDA Grand Rounds - Pharmacovigilance in Practice: From Safety Signals to Regulatory Action
