Franklin

U.S. Drug Approval Process [electronic resource] : A Primer.

Author/Creator:
Library of Congress. Congressional Research Service.
Publication:
[S.l] : [publisher not identified], 2001.
Format/Description:
Government document
Book
1 online resource (19 pages) : digital, PDF file
Subjects:
Medical laws and legislation.
Medicine -- Research.
Product safety.
System Details:
System requirements: PDF reader software.
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.
Other format:
Microfiche version: Library of Congress. Congressional Research Service. U.S. Drug Approval Process
Access Restriction:
Restricted for use by site license.
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