Drug Master Files (DMF) - Recorded Webinar with FDA Dr Arthur B. Shaw
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
On Monday 14 November 2011, the FDA presented a webinar entitled "Introduction to the Drug Master File (DMF)". This free of charge webinar discussed all aspects of filing a DMF, including
- when and why to submit a DMF
- requirements and recommendations for formatting and submitting original DMFs and subsequent submissions
- how DMFs are reviewed and common problems.
A recording of this webinar is now available. The presenter, Dr Arthur Shaw, is CDER’s DMF Expert in addition to being a Quality Reviewer in the Office of New Drug Quality Assessment (ONDQA). He has extensive experience in dealing with DMF filing and database issues as well as in reviewing many DMFs for technical content as part of his daily review work to support New Drug Applications (NDAs) and Investigational New Drug (IND) applications.
To watch the webinar please go to: "Introduction to the Drug Master File".
Here you can download the presentation files of the DMF Webinar.
Related GMP News
22.04.2026IPEC: Updated Qualification Guide
15.04.2026Ph. Eur.: Updated Guidelines for analytical Balances now available
08.04.2026EMA/CHMP: Updated Guideline on Active Substances published
01.04.2026CMDh/EMA: New Update to Appendix 1 on Nitrosamines
25.03.2026EDQM: How should the Specification of a Substance be Presented in a CEP Application?
25.02.2026EMA: Reflection Paper on Non-Mutagenic Impurities published