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Clin. Pharmacol. Ther. · Sep 2013
The PCAST report on pharmaceutical innovation: implications for the FDA.
- J Woodcock.
- Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. Janet.Woodcock@fda.hhs.gov
- Clin. Pharmacol. Ther. 2013 Sep 1; 94 (3): 297-300.
AbstractIn September 2012, the President's Council of Advisors on Science and Technology (PCAST) released the report "Propelling Innovation in Drug Discovery, Development and Evaluation." A product of discussions with many stakeholders, the report reiterates current problems in drug development, including diminished return on basic biomedical research. The report calls for doubling the current annual output of innovative new medicines--an ambitious goal. Recommendations and resulting initiatives will probably affect the FDA's drug regulatory programs.
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