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Annual FDA update on Phase IV studies proposed under latest Senate FDA reform draft bill.

This article was originally published in The Tan Sheet

Executive Summary

PHASE IV STUDY ANNUAL FDA UPDATE PART OF SENATE REFORM BILL in its latest incarnation. Under the reform bill (S 830) as it stood at the beginning of the August congressional recess, FDA would publish updates annually on specific postmarketing commitments for Rx and Rx-to-OTC switch products. FDA "shall annually develop and publish in the Federal Register a report that provides a status of the postmarketing studies that sponsors have entered into agreements to conduct and for which reports have been submitted," a draft version of the bill states.

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