FDA Announces Availability of Draft Guidance – Drug Master Files

FDA Announces Availability of Draft Guidance – Drug Master Files

FDA announced today the availability of a draft guidance for industry entitled "Drug Master Files."  Once finalized, this guidance will provide 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 are submitted solely at the discretion of their holders and are not required by statute or regulation.  

This draft guidance, when finalized, will revise the guidance for industry "Drug Master Files: Guidelines" that published in September 1989.  Most of the information contained in the 1989 guidance has been retained and reorganized in this draft guidance.  Additionally, this update includes a change in FDA’s contact person for the guidance, new procedures for DMFs referenced in abbreviated new drug applications that reflect commitments under GDUFA, more detailed instructions regarding the submission of original DMFs versus amendments, reference to the electronic submission requirements under section 745A of the Federal Food, Drug, and Cosmetic Act that apply to certain DMFs, removal of Type I** as a DMF category, and clarification and reorganization of material associated with Type III and Type IV DMFs.

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. For additional information, see FDA’s DMF web pages.

Comments or suggestions regarding this draft guidance can be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to https://www.regulations.gov. Written comments can be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with docket number FDA-2019-D-3989.

** Type I DMFs were discontinued in 2000 but the numbering of the other DMF types has not changed.

For more information, please visit: DMFs.