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FDA Announces Public Meeting on BsUFA Reauthorization –

October 26, 2026

The U.S. Food and Drug Administration is hosting a public meeting on October 26, 2026, to discuss proposed recommendations for the fourth reauthorization of the Biosimilar User Fee Amendments (BsUFA IV).  The meeting will provide stakeholders an opportunity to share input on the recommendations.

When: October 26, 2026, 9 AM – 12 PM EST

Format: Hybrid (In-person/Virtual)

Registration: Required – Register for the public meeting 

Your participation and input are valuable as FDA prepares for the next reauthorization cycle. Please see the Federal Register Notice for more details about the public meeting, opportunities for public comment, and proposed enhancements for BsUFA IV.

For more information about BsUFA IV and the reauthorization process, visit the BsUFA IV reauthorization webpage.

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