FDA Announces BsUFA III Regulatory Science Program Funding Opportunity

The FDA has recently announced an exciting funding opportunity for the fiscal year 2023. The agency is inviting researchers to submit their innovative projects aimed at enhancing biosimilar and interchangeable biological product development and regulatory science. With a view to advancing the development of interchangeable products, the focus of the funding opportunity is on improving the efficiency of biosimilar product development. The selected projects should aim to increase the accuracy and capability of analytical characterizations and chemistry, manufacturing, and controls. The agency is also looking for alternative methods to reduce the size of studies involving human subjects.

If you're interested in applying, the FOA provides details on the projects of particular interest, such as the use of analytical device information, identification of user interface differences, and development of methods to determine acceptable differences. Check out the FOA to learn more about this opportunity and how to submit proposals. The funding opportunity will be open for submissions until April 26, 2023. Don't miss out on this fantastic opportunity to contribute to the advancement of biosimilar and interchangeable biological product development! For more information on biosimilars, visit www.fda.gov/biosimilars.

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