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The Globalization of clinical trials : a growing challenge in protecting human subjects / Department of Health and Human Services, Office of Inspector General.

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Format:
Book
Government document
Author/Creator:
United States. Department of Health and Human Services. Office of Inspector General, author.
Language:
English
Subjects (All):
United States. Food and Drug Administration--Auditing.
United States.
United States. Food and Drug Administration.
Clinical trials--Government policy--United States.
Clinical trials.
Drugs--Testing--Government policy--United States.
Drugs.
World health.
Human experimentation in medicine.
International cooperation.
Human beings.
Humans.
Clinical Trials as Topic.
Global Health.
Drug Approval--legislation & jurisprudence.
Drugs, Investigational.
Human Experimentation.
International Cooperation.
Safety.
Homo sapiens (species).
Auditing.
Clinical trials--Government policy.
Drugs--Testing--Government policy.
Medical Subjects:
Humans.
Clinical Trials as Topic.
Global Health.
Drug Approval--legislation & jurisprudence.
Drugs, Investigational.
Human Experimentation.
International Cooperation.
Safety.
Genre:
Fulltext.
Govt Pub, Federal.
Internet Resource.
Technical Reports.
Online resources.
Physical Description:
1 online resource (iv, 51 pages) : illustrations, map
Place of Publication:
[Washington, D.C.] : Department of Health and Human Services, Office of Inspector General, 2001.
Summary:
Documents the growth of non-United States clinical drug trials contributing data to New Drug Applications for Food and Drug Administration (FDA) approval, and to assess FDA's capacity to assure human subject protections in these trials.
Notes:
Title from title screen (viewed June 10, 2011).
"OEI-01-00-00190."
"September 2001."
Includes bibliographical references (pages 43-51).
OCLC:
732600615

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