Drug Master Files (DMFs) Guidance for Industry

On 18 October 2019 FDA announced the availability of this draft guidance. Once finalized, this guidance will provide FDA's current thinking on DMFs. Comments may be submitted by December 12, 2019.

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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