http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
Background and Issues for PDUFA IV Reauthorization
Reviews reauthorization issues for the Prescription Drug User Fee Act (PDUFA) of 1992, which authorizes FDA to impose drug approval application fees on drug manufacturers to fund new drug and biologic product safety review activities. Evaluates effectiveness of PDUFA program; and summarizes arguments for and against program reauthorization.
Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Dec. 2010). Reuse except for individual research requires license from ProQuest, LLC.
Library of Congress. Congressional Research Service.