TITLE

FDA unveils regulatory science plan

AUTHOR(S)
Kondro, Wayne
PUB. DATE
September 2011
SOURCE
CMAJ: Canadian Medical Association Journal;9/20/2011, Vol. 183 Issue 13, pE1014
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The article reports that the U.S. Food and Drug Administration (FDA) has unveiled their "Advancing Regulatory Science at FDA" strategic plan to improve their capacity to oversee drug, biologics, and medical devices development safety. It says that the plan contains methods to measure human susceptibility to drug side affects, assess clinical trial design, and determine human risk. Also included are the eight priority areas of the FDA like toxicology modernization, and clinical evaluations.
ACCESSION #
66287419

 

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