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Warnings for Clinical Trials Show Four-Year Uptrend

September 8, 2009

Warnings because of Clinical Trials Show Four-Year Uptrend
CDER’s Division of Scientific Investigations (DSI) has been sending out some increasing number of warning letters on the conduct of clinical trials over the past four years. The number of letters more than doubled from 10 in fiscal 2006 to 22 from last Oct. 1 from one side Aug. 21, according to figures provided by DSI Director Leslie Ball. The majority of omen letters in the four-year span went to clinical investigators — from five in financial 2006 to 18 so more distant this financial year.

Written by Samanta · Filed Under FDA News