U.S. Drug Approval Process A Primer

Format:

Book

Government document

Author/Creator:

Library of Congress. Congressional Research Service

Language:

English

Subjects (All):

Medical laws and legislation.

Medicine--Research.

Medicine.

Product safety.

Physical Description:

1 online resource

Contained In:

ProQuest U.S. Congressional Research Digital Collection

Place of Publication:

[Washington, D.C.] [publisher not identified] 2001

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

Notes:

CRS Report

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

Vendor supplied data

Other Format:

Microfiche version Library of Congress. Congressional Research Service. U.S. Drug Approval Process

Publisher Number:

CRS-2001-DSP-0032

Access Restriction:

Restricted for use by site license