TITLE

FDA's Consideration of Evidence from Certain Clinical Trials

AUTHOR(S)
Crosse, Marcia
PUB. DATE
August 2010
SOURCE
GAO Reports;8/30/2010, preceding p1
SOURCE TYPE
Government Document
DOC. TYPE
Article
ABSTRACT
The article discusses a study conducted by the U.S. Government Accountability Office (GAO) on the Food and Drug Administration's (FDA's) decision for drug approval. The GAO examined the FDA's use of non-inferiority trial evidence to assess drug effectiveness by looking at new drug applications (NDAs), characteristics of trials, and the FDA's guidance on trials. The GAO found that the FDA has become more conservative in allowing evidence from such trials to demonstrate a drug's effectiveness.
ACCESSION #
53752972

 

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