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Product safetyFDAUnited StatesImports

Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments

25 September 2026

In plain English

FDA is holding a public meeting and seeking comments on proposed recommendations to reauthorize the Biosimilar User Fee Act for FY2028 through FY2032.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
25 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA, the Agency, or we) is hosting a hybrid public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2028 through 2032. The BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological product applications. The current legislative authority for BsUFA expires in September 2027. At that time, new legislation will be required for FDA to con
The full text is at the source

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