Docket Number:
FDA-2019-D-4258
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

A drug master file (DMF) is a voluntary submission to FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The draft guidance for industry Drug Master Files (October 2019) (hereinafter DMF guidance) and the DMF web page identify the types of DMFs that may be submitted. A Type V DMF is intended for the submission of FDA-accepted reference information and supporting data that are not covered by DMF Types II–IV.

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