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Using REMS to Ram Drugs through the FDA Faster

Executive Summary

FDA's use of Risk Evaluation & Mitigation Strategies will require NDA and BLA sponsors to provide more rigorous definitions of patient populations. Former FDA Commissioner Kessler thinks that may break the logjam on approvals. (Sidebar to the article, "Evolution in Strategies for Getting FDA Approvals." ) This is a sidebar to the article, "The New World for New Drug Approvals: Evolution in Strategies for Getting FDA Approvals."
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