Postmarketing Study Status To Be Defined By Trial Making Least Progress
This article was originally published in The Tan Sheet
Executive Summary
The overall status of a company's postmarketing commitment for a product will be determined by the study which has made the least progress, according to an FDA draft guidance.
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Postmarketing guidance
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...
Postmarketing guidance
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...
Postmarketing guidance
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...