Prescription Drug User Fee Act (PDUFA) : Background and Issues for PDUFA IV Reauthorization.

Format:

Book

Government document

Author/Creator:

Library of Congress. Congressional Research Service.

Language:

English

Subjects (All):

Consumer protection.

Drugs.

Medical laws and legislation.

Physical Description:

1 online resource (21 pages, digital, PDF file)

Place of Publication:

[Place of publication not identified] : [publisher not identified], 2007.

System Details:

text file

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.

Notes:

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.

Other Format:

Microfiche version: Library of Congress. Congressional Research Service. Prescription Drug User Fee Act (PDUFA)

Access Restriction:

Restricted for use by site license.