- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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 The draft guidance for industry Drug Master Files (October 2019) (hereinafter DMF guidance) and the DMF web page identify the types of DMFs that may be submitted.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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2019-D-4258.