Administrative Aspects of Managing a Drug Master File (DMF)

FDA discusses the administrative timeline of a DMF. This includes requesting a pre-assigned DMF number, progression of status form pending to active, subsequent submissions, and advice on administrative aspects of managing a DMF.
Presenter:
Vathsala Selvam, Technical Information Specialist
Division of Lifecycle API
ONDP/OPQ/CDER
Learn more at: www.fda.gov/drugs/news-events...
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