Prescription Drug User Fee Act (PDUFA) : 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 argument...

Full description

Bibliographic Details
Corporate Authors:	Library of Congress. Congressional Research Service, ProQuest (Firm)
Format:	eBook
Language:	English
Published:	[Place of publication not identified] : [publisher not identified], 2007.
Series:	U.S. Congressional Research.
Subjects:	Consumer protection. Drugs. Medical laws and legislation. Electronic books.
Online Access:	Connect to the full text of this electronic book

Description
Summary:	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.
Item Description:	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. CRS Report. Electronic resource.
Physical Description:	1 online resource.