Advancing the Development of Interchangeable Products: Identifying Future Needs; Public Workshop; Request for Comments
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
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.
Abstract as published in the Federal Register.
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