Events | 2017.10.09
FDAnews Announces — New Book — Clinical Trials Adverse Event Reporting Guide, 2017 Edition
The FDA requires clinical trial sponsors to report any patient’s serious adverse drug reaction if the sponsor determines that the “information qualifies for reporting” under section 312.32 of its Investigational New Drug Application rules. A lot rides on that simple four-word phrase.
(PRWeb October 09, 2017)
Read the full story at http://www.prweb.com/releases/FDAnews/ctadverseeventreporting/prweb14756180.htm
For more information, please visit
http://www.prweb.com/releases/FDAnews/ct[...]entreporting/prweb14756180.htm
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