FDA announces funding opportunity for the BsUFA III regulatory science program
The US Food and Drug Administration yesterday published a funding opportunity announcement (FOA) to support research projects that enhance biosimilar and interchangeable biological product development and regulatory science.
As outlined in the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023-2027 (BsUFA III), the FDA will pilot a regulatory science program to facilitate biosimilar and interchangeable biological product development.
The FOA provides information about the opportunity to enhance biosimilar and interchangeable biosimilar product development and regulatory science, specifically to improve the efficiency of biosimilar product development and advance the development of interchangeable products. While the FDA will begin receiving proposals in advance, all awards will be subject to funding and reauthorization of BsUFA.
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