FDA Creates Guide to Help Find Right FDA Office
Published Date: 11/26/2025
Notice
Summary
The FDA just dropped a draft guide to help companies know exactly where to send their master files when they support multiple product reviews across different FDA centers. This makes the process smoother for folks working with drugs, biologics, devices, and veterinary products. If you’re in the industry, check it out and send your feedback by February 24, 2026—no fees, just better clarity and faster reviews!
Analyzed Economic Effects
5 provisions identified: 4 benefits, 1 costs, 0 mixed.
Where to Submit Cross‑Center Master Files
If you hold a master file that may be accessed by more than one FDA center, FDA published a draft guidance that gives recommendations on which center to submit that master file. The recommendations explicitly cover submissions to CBER, CDER, and CDRH and to certain types of CVM master files.
CVM Types VI–VIII Are Excluded
The draft guidance applies to master files submitted to the Center for Veterinary Medicine (CVM) except it does not apply to CVM veterinary master file types VI, VII, and VIII and their Public Master Files. Holders of those CVM master file types are not covered by these recommendations.
Draft Guidance Is Non‑Binding
The document is a draft guidance and, as stated, represents FDA's current thinking and is not binding on FDA or the public. You may use an alternative approach if it satisfies the applicable statutes and regulations.
No New Paperwork Under PRA
The draft guidance contains no new collection of information under the Paperwork Reduction Act. It refers to previously approved FDA collections with OMB control numbers such as 0910-0001, 0910-0014, 0910-0338, 0910-0032, and others.
Applies to New Master File Submissions
FDA states that the recommendations, once finalized, are intended for new master file submissions going forward. The draft guidance asks for comments by February 24, 2026 as FDA develops the final guidance.
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