TITLE

FDA says it must strengthen its scientific base to regulate drug safety

AUTHOR(S)
Kondro, Wayne
PUB. DATE
September 2011
SOURCE
CMAJ: Canadian Medical Association Journal;9/6/2011, Vol. 183 Issue 12, pE796
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The article focuses on the "Identifying CDER's Science and Research Needs Report." According to the report, the Center for Drug Evaluation and Research (CDER) of U.S. Food and Drug Administration (FDA) needs to understand patients' use of unapproved drugs so it can fully accomplish its regulatory responsibilities. It mentions some areas in which FDA must bolster its capabilities including improved risk assessment strategy, enhanced patient treatment individualization, and clinical trial design.
ACCESSION #
65928294

 

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