FIAU WARNING LETTER MAY ENCOURAGE "OVER-REPORTING" OF ADVERSE EVENTS, LILLY
Executive Summary
FIAU WARNING LETTER MAY ENCOURAGE "OVER-REPORTING" OF ADVERSE EVENTS, LILLY alleges in its June 29 response to FDA's May 11 warning letter regarding the conduct of a Phase I/II study of the antiviral fialuridine. Responding to FDA's claim that Lilly did not promptly report adverse events seen in the study, Lilly maintained that "questioning Lilly's good faith judgments... would only encourage companies to over-report adverse events, which would serve no useful purpose."