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Postmarketing guidance

This article was originally published in The Tan Sheet

Executive Summary

An updated guidance for industry "provides recommendations on procedures, content and format for submitting a postmarketing study status report," FDA announces in the Feb. 16 Federal Register. "Reports on the Status of Postmarketing Study Commitments" also provides "timeframes for FDA's review of postmarketing study commitments; and information about postmarketing study commitments that will be available to the public." The guidance replaces an April 2001 version of the guidance, which was published following the issuance of a final rule on postmarketing study status reports in October 2001 (1"The Tan Sheet" April 16, 2001, p. 6). The overall status of a company's postmarketing commitment is still determined by the study which has made the least progress, according to the guidance...

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