CRS Report for CongressPrepared for Members and Committees of Congress Proposed FDA User Fee Acts: Generic Drug User Fee Amendments of 2012 (GDUFA) and Biosimilar User Fee Act of 2012 (BSUFA) (name redacted) Specialist in Drug Safety and Effectiveness (name redacted) Specialist in Biomedical Policy May 18, 2012 Congressional Research Service 7-. www.crs.gov R42540