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).
DMF holders can authorize one or more applicants or sponsors to incorporate by reference information contained in the DMF without having to disclose that information to the applicants or sponsors. DMFs are submitted solely at the discretion of their holders and are not required by statute or regulation. They are not typically submitted for nonproprietary materials. DMFs can be used to support (but are not substitutes for) applications reviewed by FDA
Additionally, information contained in DMFs can generally be referenced in premarket submissions for devices (e.g., premarket approvals) and animal drugs (e.g., new animal drug applications).
This guidance provides information about preparing and submitting DMFs. It describes DMF types, the information needed in DMF submissions, and FDA’s DMF review processes
This guidance revises the guidance for industry Drug Master Files: Guidelines that published in September 1989. Most of the information contained in the 1989 guidance has been retained here, with significant reorganization.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
