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The guidance document discusses the preparation and submitting of drug master files as well as FDA’s review process.
FDA announced the publication of draft guidance on drug master files on October 18, 2019. The new guidance revises the agency’s September 1989 guidance, Drug Master Files: Guidelines and details the preparation and submission of drug master files (DMFs).
DMFs are submissions to FDA that provide “confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.” DMFs may also contain toxicology information and shared system risk evaluation and mitigation strategies. DMFs may be used to support new drug applications, abbreviated new drug applications, and investigational new drug applications. They may also support biologics license applications under the Public Health Service Act. DMFs themselves are not approved by FDA but the technical contents of DMFs may be reviewed in connection with the applications that reference them, according to the agency.
The new guidance discusses the types of DMFs, how to submit DMFs including format and delivery, and how to report changes to DMFs. The guidance also details FDA review processes including administrative review and technical review.