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Forum Initiatives
Pages 10-13

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From page 10...
... In February 2010, the Forum held a workshop that examined the state of the science of drug regulation and considered approaches for enhancing the scientific basis of regulatory decision making. Also, since 2007, the Forum has hosted public meetings designed to engage congressional staff and the broader policy community on current topics in drug development.
From page 11...
... clinical trial enterprise: one working group considered issues pertaining to the regulation and infrastructure of clinical trials in the United States, and the other looked at ways to enhance public engagement in the clinical research enterprise. April 27 September 2 Workshop: Streamlining Discussion Series: FDA October 15–16 Clinical Trial and Material Community Update on Forum Meeting #14 Transfer Negotiations Post-Market Drug Safety July 10 Symposium: Drug Regulation with October 7–8 April 27–28 FDA Commissioner, Peggy Hamburg Workshop: Transforming Clinical Forum Meeting #12 (Forum Meeting #13)
From page 12...
... Promoting Public Understanding of Drug Development Successful introduction of new therapeutic entities requires testing in an informed and motivated public. The Forum has spent concerted effort to understand what limits public par ticipation and how to enhance more widespread acceptance of the importance of advancing therapeutic development through public participation in the drug development process.
From page 13...
... This document summarizes the workshop. Transforming Clinical Research in the United States: Challenges and Opportunities -- Workshop Summary Released: August 2, 2010 The IOM held a public workshop October 7–8, 2009, to evaluate the state of clinical research in the United States, and to identify strategies for improving clinical trials' efficiency and effectiveness.


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