Opportunities for Improving the Drug Development Process : Results from a Survey of Industry and the FDA

Ernst R. Berndt, Adrian H. B. Gottschalk, Matthew W. Strobeck

Based on our survey and discussions, we uncovered several thematic opportunities to improve interactions between the FDA and industry and to reduce clinical development times: 1) develop metrics and goals at the FDA for clinical development times in exchange for PDUFA like fees; 2) establish an oversight board consisting of industry, agency officials, and premier external scientists (possibly at NIH or CDC) to evaluate and audit retrospectively completed and terminated drug projects; and 3) construct a knowledge database that can simultaneously protect proprietary data while allowing sponsor companies to understand safety issues and problems of previously developed/failed drug programs

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Year of publication:	June 2005
Authors:	Berndt, Ernst R.
Other Persons:	Gottschalk, Adrian H. B. (contributor) ; Strobeck, Matthew W. (contributor)
Institutions:	National Bureau of Economic Research (contributor)
Publisher:	Cambridge, Mass : National Bureau of Economic Research
Subject:	Pharmakologie \| Pharmacology \| Pharmaindustrie \| Pharmaceutical industry \| Aufsichtsbehörde \| Regulatory agency \| Kommunikation \| Communication

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