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Drug Master File
Drug Master File or DMF is a document prepared by a manufacturer in the pharmaceutical industry and submitted solely at his discretion to the Food and Drug Administration (FDA). There is no requirement by law or FDA regulation to present a DMF. The document 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.
Additional recommended knowledge
FDA: Guideline for drug master files
DMF search engine
|This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Drug_Master_File". A list of authors is available in Wikipedia.|