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FDA REFORM ACT'S EDUCATION AND RESEARCH CENTERS HAVE WIDE MANDATE, GIVING AGENCY LATITUDE IN RESEARCH TOPICS; LAW LOOSENS FDA'S OFF-LABEL DATA POLICY

This article was originally published in The Gray Sheet

Executive Summary

The broad mandate of the centers for education and research on therapeutics established by Sec. 409 of the FDA Modernization Act (S 830), which was signed into law Nov. 21, and the modest appropriations level authorized in the bill for the new centers suggests that FDA will have considerable discretion in deciding which research projects the centers choose to pursue.
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