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ANNUAL IND SAFETY SUMMARIES ARE "DESIRABLE" BUT SEMI-ANNUAL REPORTS ARE UNJUSTIFIED FOR NEW ADR REPORTING REGS: PhRMA ASKS FOR DELAY IN ISSUING REGS

Executive Summary

The addition of safety summaries to IND annual reports would be useful, but semi-annual safety reports are unnecessary, the Pharmaceutical Research & Manufacturers of America maintains in recent comments on FDA recommendations for changes in adverse event reporting. The comments also cover the conduct of early clinical trials as described in FDA's task force report on Lilly/Oclassen's FIAU (fialuridine) toxicity released in November 1993 ("The Pink Sheet" Nov. 22, 1993, p. 15).
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PS024877

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