On October 18, 2019, FDA issued draft guidance on Drug Master Files, which are optional submissions to FDA that provide confidential, detailed information about facilities, processes, or articles used in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 can be used to support NDAs, ANDAs, INDs, and BLAs, and information contained in DMFs can also generally be referenced in premarket submissions for devices and animal drugs. The draft guidance revises a previously published draft guidance from September 1989, with most changes involving reorganization of the information.
The FDA intends this guidance to provide information about preparing and submitting DMFs, including by describing the types of DMFs, the information needed in DMF submissions, and FDA’s DMF review processes. The guidance begins by identifying the four DMF types, numbered II through V, noting that Type I was discontinued in 2000. The guidance also discusses the format and delivery of DMF submissions and provides submission recommendations, including some that are specific to DMF type. FDA’s DMF review includes an administrative review followed by a technical review. FDA will contact the DMF holder if there is incomplete administrative information, if additional information is needed to continue a review, if the DMF cannot be used to support approval of the application or allow clinical trials to proceed, or if FDA cannot be assured that a DMF is current.