FDA Seeks Input on Generic Drug Paperwork Efficiency
Published Date: 1/17/2025
Notice
Summary
The FDA is asking for public feedback on using a special Type V Drug Master File to help speed up generic drug approvals. This change could make it easier and faster for drug companies to submit important info for new generic medicines. If you’re involved in drug development, you have until April 17, 2025, to share your thoughts—so don’t miss out!
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Type V DMF may speed generic approvals
FDA states that using a Type V Drug Master File (DMF) to house Model Master Files (MMFs) may help advance generic drug development and facilitate the review and approval of Abbreviated New Drug Applications (ANDAs). The notice explicitly says leveraging MMFs via a Type V DMF "may help" make ANDA review and approval processes easier and faster.
How Type V DMFs and MMFs would work
FDA explains that a DMF is a voluntary, confidential submission; a Type V DMF is used for "FDA-accepted reference information." A Type V DMF holder can authorize one or more ANDA applicants to incorporate by reference the MMF information without giving the underlying confidential data to those applicants. Prospective DMF holders should email a letter of intent to the DMF staff (the notice cites sending the letter to the DMF staff email provided in FDA guidance) and Type V DMFs may be submitted on an ongoing basis.
Public docket and comment deadline
The FDA opened a public docket (Docket No. FDA-2024-N-5975) asking for comments on using a Type V Drug Master File for Model Master File submissions to support Abbreviated New Drug Applications. You can submit comments electronically at https://www.regulations.gov or by mail; comments must be received by April 17, 2025. If you want to submit confidential information, follow the written/paper submission instructions and include a copy marked "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION."
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