Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary

The Food And Drug Administration (fda) Is Tasked With Ensuring The Safety And Effectiveness Of Medicine. Fda's Science Base Must Be Strong Enough To Make Certain That Regulatory Decisions Are Based On The Best Scientific Evidence. The Iom Held A Public Workshop On February 26, 2010, To Examine The State Of Regulatory Science And To Consider Approaches For Enhancing It.--publisher's Description. Introduction -- Defining Regulatory Sciences -- The Urgent Need For Regulatory Science -- Barriers To Enhanced Regulatory Science -- Potential Models For Building A Regulatory Science Infrastructure -- Challenges In Engaging The Public Policy Community -- Envisioning Successsful Regulatory Science At Fda -- Considering Next Steps. Yeonwoo Lebovitz, Rebecca A. English And Anne B. Claiborne, Rapporteurs ; Forum On Drug Discovery, Development, And Translation, Board On Health Sciences Policy, Institute Of Medicine Of The National Academies. Includes Bibliographical References (pages 53-55).