Challenges for the FDA : the future of drug safety : workshop summary / Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies ; Leslie Pray and Sally Robinson, rapporteurs.
Includes bibliographical references (pages 78-79).
Contents
Addressing the FDA's Resource Challenges -- Strengthening the Scientific Base of the Agency -- Integrating Pre- and Postmarket Review -- Enhancing Postmarket Safety Monitoring -- Conducting Confirmatory Drug Safety and Efficacy Studies -- Enhancing the Value of Clinical Trial Registration -- Enhancing Postmarket Regulation and Enforcement -- Looking to the Future.
Local Note
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