FDA Revised Draft Guidance on Drug Master Files

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Drug Master Files.”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. This draft guidance, when finalized, will revise the guidance for industry “Drug Master Files: Guidelines” that published in September 1989.

FDA said that the update includes new procedures for DMFs referenced in abbreviated new drug applications (ANDAs), more detailed instructions on submitting original DMFs versus amendments, reference to the electronic submission requirements under section 745A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that apply to certain DMFs, clarification and reorganization of material associated with Type III and Type IV DMFs and a change in FDA’s contact person for the guidance.

The guidance also features information on the format and delivery of DMFs, submitting original DMFs in eCTD format, submission recommendations by DMF type and FDA processing and review policies. The agency also touches on the differences between DMFs for BLAs and DMFs for applications under the FD&C Act.

A footnote says, “Although FDA’s approach to the use of master files in BLAs under the PHS Act largely parallels its approach to the use of DMFs in applications under the FD&C Act, there is a significant difference: a BLA holder is generally expected to have knowledge of and control over the manufacturing process for the biological product for which it has a license. For biological products in BLAs under the PHS Act, FDA has, as a scientific matter, generally not permitted applicants to incorporate information about drug substance, drug substance intermediate, or drug product by reference to a master file; rather, FDA generally expects such information to be submitted directly to the BLA.”

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