Report of a workshop on confirmatory evidence to support a single clinical trial as a basis for new drug approval

Drug Information Journal

Volumn 36, Issue 3, 2002, Pages 517-534

  Peck, Carl C ^a   Wechsler, Jill ^a  

^a GEORGETOWN UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Confirmatory evidence; Drug approval standards; Evidence of effectiveness; FDAMA Section 115a; Single clinical trial

Indexed keywords

CLINICAL TRIAL; CONFERENCE PAPER; DRUG APPROVAL; ECONOMIC ASPECT; FOOD AND DRUG ADMINISTRATION; LAW; POLICY; PRIORITY JOURNAL; PUBLICATION; REGULATORY MECHANISM; RISK BENEFIT ANALYSIS; SAFETY;

EID: 0036378736     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150203600307     Document Type: Conference Paper

References (9)

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4. Statement Regarding the Demonstration of Effectiveness of Human Drug Products and Devices. Federal Register. 60;147, August 1, 1995:39,180.
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6. Senate Report 105-43; Food and Drug Administration Accountability Act of 1997, Title IV Improving Certainty and Clarity of Rules, pg. 30.
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9. Milne CP. The single controlled trial: industry survey indicates implementation is still a work in progress. Drug Inf J. 2002.