FDA Announces Funding Opportunity for the BsUFA III Regulatory Science Program
Today, the U.S. Food and Drug Administration 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), 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 FDA will begin receiving proposals in advance, all awards will be subject to funding and reauthorization of BsUFA.
Please see the FOA for details about this opportunity and how to submit proposals. For more details regarding desired research objectives, refer to the BsUFA III commitment letter, Section II.E.”
FDA is committed to enhancing regulatory decision-making and facilitating science-based recommendations in areas foundational to biosimilar development.
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