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Postmarketing Study's "End Of Usefulness" Must Be Confirmed By FDA

This article was originally published in The Tan Sheet

Executive Summary

Industry must continue to submit status reports on terminated postmarketing drug studies until FDA concurs the studies will provide no more useful information under a proposed revision to postmarketing study status annual reporting regs published in the Dec. 1 Federal Register.

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Postmarketing Study Status Reports Need Sponsor Pre-Clearance - PhRMA

Portions of postmarketing study annual status reports that will be publicly disclosed should be pre-specified by study sponsors, the Pharmaceutical Research & Manufacturers of America suggests to FDA in Feb. 14 comments.

Postmarketing Study Status Reports Need Sponsor Pre-Clearance - PhRMA

Portions of postmarketing study annual status reports that will be publicly disclosed should be pre-specified by study sponsors, the Pharmaceutical Research & Manufacturers of America suggests to FDA in Feb. 14 comments.

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