U.S. Drug Approval Process : A Primer.

Gives historical background and examines the FDA drug approval process and post-marketing surveillance. Reviews how "drug" is defined under Federal law, examines drug safety and effectiveness, preclinical research and testing, the drug application process, clinical trials, FDA review, and...

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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], 2001.
Series:	U.S. Congressional Research.
Subjects:	Medical laws and legislation. Medicine > Research. Product safety. Electronic books.
Online Access:	Connect to the full text of this electronic book

Description
Summary:	Gives historical background and examines the FDA drug approval process and post-marketing surveillance. Reviews how "drug" is defined under Federal law, examines drug safety and effectiveness, preclinical research and testing, the drug application process, clinical trials, FDA review, and generic drug approval.
Item Description:	Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed July 2010). Reuse except for individual research requires license from ProQuest, LLC. CRS Report. Electronic resource.
Physical Description:	1 online resource.