Research ReportCRS ReportVersion 3
R42540
Proposed FDA User Fee Acts: Generic Drug User Fee Amendments of 2012 (GDUFA) and Biosimilar User Fee Act of 2012 (BSUFA)
Published May 18, 2012Updated Jun 20, 2025
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The Congressional Research Service is a nonpartisan policy and legal analysis arm of the Library of Congress. CRS reports are written for members of Congress and their staff, not the public — but they’re made available openly through Congress.gov.