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Notice2025-15572

Advancing the Development of Interchangeable Products: Identifying Future Needs; Public Workshop; Request for Comments

Primary source

Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published
August 15, 2025

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Advancing the Development of Interchangeable Products: Identifying Future Needs." The purpose of the public workshop is to address a commitment FDA made in the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years (FYs) 2023 through 2027 (BsUFA III) to hold a scientific workshop to discuss and identify future needs (e.g., guidance, research) that, when addressed, may help further advance the development of interchangeable biosimilar products.

Indexed from Federal Register on August 15, 2025.

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