Docket Number:
FDA-2019-D-3989
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides FDA’s current thinking on drug master files (DMFs), which are submissions 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 human drug products. DMFs can contain other types of information as well (e.g., toxicology information, shared system REMS (risk evaluation and mitigation strategy)).

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All written comments should be identified with this document's docket number: FDA-2019-D-3989.