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Product safetyFDAUnited StatesImports

Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document

18 September 2026

In plain English

FDA published a draft BsUFA III strategy document summarizing its September 19, 2025 workshop on future needs for developing interchangeable biosimilar products.

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

From the notice

The Food and Drug Administration (FDA or Agency) is announcing the publication of a draft strategy document titled "BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document" (Strategy Document). This draft Strategy Document is intended to summarize the discussion that occurred at the FDA public workshop, "Advancing the Development of Interchangeable Products: Identifying Future Needs," held on September 19, 2025, and to describe FDA's future direct
The full text is at the source

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