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FDA Announces BsUFA III Regulatory Science Program to Support Future Research

February 17, 2023


FDA published a funding opportunity announcement (FOA) for fiscal year 2023 to support research projects that improve biosimilars, interchangeable biological product development, and regulatory science. The Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023–2027 (BsUFA III) highlights that FDA will start a regulatory science program to facilitate biosimilar and interchangeable biological product development. The intention of the FOA is to address diverse topics related to improving the efficiency of biosimilar product development and advancing the development of interchangeable products.

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