FDA Learns By Doing In Using REMS Powers; Guidance In “Future”

07 Jul 2008
News

Cathy Dombrowski cathy.dombrowski@informa.com

Executive Summary

FDA decisions on whether to require a risk evaluation and mitigation strategy for a new drug will continue to be made on a case-by-case basis while the agency gains on-the-job experience in interpreting requirements of the FDA Amendments Act

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FDA Learns By Doing In Using REMS Powers; Guidance In “Future”

News

Executive Summary

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