FDA Rule Aims To Improve Reporting For Drug Trials

Law360, New York (September 29, 2010, 1:58 PM EDT) -- The U.S. Food and Drug Administration has announced new rules that it said would increase the quality of safety information it receives during clinical trials of investigational drugs and biologics.

In a Federal Register notice published Wednesday, the FDA said that the rule will require certain safety information, which had not been previously required, to be reported to the agency within 15 days of an occurrence.

According to the FDA, under current rules, drug sponsors often report all serious adverse events in a trial, even if...
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