Drug Master Files (DMF)

一土山人 2012-01-05

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Drug Master Files (DMF) - Recorded Webinar with FDA Dr Arthur B. Shaw

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.