TITLE

United States clinical trial safety data reporting requirements revised

AUTHOR(S)
Kondro, Wayne
PUB. DATE
November 2010
SOURCE
CMAJ: Canadian Medical Association Journal;11/9/2010, Vol. 182 Issue 16, pE744
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The article reports that the U.S. Food and Drug Administration (FDA) has revised its clinical trial safety data reporting requirements. It notes that the revised FDA regulation will oblige companies to report to the agency within seven to 15 days all results from clinical studies that suggest a significant risk to study participants. The FDA states that the revisions will improve the utility of investigational new drug (IND) and better protect human subjects enrolled in clinical trials.
ACCESSION #
55171234

 

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