Prescription Drug User Fee Act (PDUFA) : Issues for Reauthorization (PDUFA V) in 2012.

Format:

Book

Government document

Author/Creator:

Library of Congress. Congressional Research Service.

Language:

English

Subjects (All):

Consumer protection.

Drugs.

Medical laws and legislation.

Product safety.

Physical Description:

1 online resource (1 online resource (27 p), digital, PDF file)

monochrome

Place of Publication:

[Place of publication not identified] : [publisher not identified], 2012.

System Details:

text file

Summary:

Describes origin of prescription drug user fees, and provides brief overview of the Prescription Drug User Fee Act (PDUFA), which authorizes FDA to impose drug approval application fees on drug manufacturers to fund new drug and biologic product safety review activities. Discusses impact of PDUFA on FDA application review time and FDA human drugs program budget, covers legislative language and performance goals in PDUFA V proposal, and examines reauthorization issues.

Notes:

Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Apr. 2014). 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.