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

This article was originally published in RPM Report

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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