FDA Fast Track and Priority Review Programs.

Describes mechanisms to expedite FDA development and review process for new drug and biological products, including their intended effects and statutory and regulatory bases. Examines whether fast track program increases likelihood of approval and shortens approval time.

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:	United States. > Laws, etc. (Statutes of the United States) Drugs. Government productivity. Electronic books.
Online Access:	Connect to the full text of this electronic book

Description
Summary:	Describes mechanisms to expedite FDA development and review process for new drug and biological products, including their intended effects and statutory and regulatory bases. Examines whether fast track program increases likelihood of approval and shortens approval time.
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.