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FDA, Industry Set Priorities for BsUFA III | Aspen Xchange
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Washington, D.C., USA- January13, 2020: FDA Sign at its headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

At the kickoff meeting for the reauthorization process for the Biosimilar User Fee Act (BsUFA III) program, the US FDA and industry shared their wish lists for the third iteration of the agency’s biosimilars review program. While the FDA laid out four broad goals for the FY2023-2027 program, industry presented more specific proposals, including the creation of a new pre-development meeting and issuance of further guidance on interchangeable biosimilars. The meeting, which sets the stage for the months long negotiations between the FDA and regulated industry, began with an overview of the BsUFA program by Patrizia Cavazzoni, acting director of CDER and Andy Kish, director of the Office of Program and Strategic Analysis at CDER.
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