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BioPharmaceutical Regulation

IoM Will Address Ethics in Safety Studies Prior To Avandia Advisory Committees

This article was originally published in RPM Report

  • Analysis

Executive Summary

FDA is acting to create political and scientific cover for the second public review of Avandia safety issues in mid-July. A former top staffer to House Energy & Commerce Chairman Waxman is doing an internal study of agency post-marketing safety procedures to assure Capitol Hill that FDA takes the issue seriously; an IoM workshop is convening in early June to prepare a preliminary review on the ethical issues with post-market safety studies.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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