Industry funding of the FDA: effects of PDUFA on approval times and withdrawal rates

Author:

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

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmacology,General Medicine

Reference28 articles.

1. DiMasi, J. A., Hansen, R. W. & Grabowski, H. G. The price of innovation: new estimates of drug development costs. J. Health Econ. 22, 151–186 (2003).

2. US Food and Drug Administration. CBER About Us. [online], < http://www.fda.gov/cber/about.htm > (2005).

3. PAREXEL's Pharmaceutical R&D Statistical Sourcebook 2003/2004 (ed. Mathiew, M. P.) 184 (Parexel International Corp., Waltham, 2003).

4. Grabowski, H. G., Vernon, J. H. & DiMasi, J. A. Returns on research and development for 1990s new drug introductions. PharmacoEconomics 20 (Suppl. 3), 11–29 (2002).

5. Carpenter, D., Chernew, M., Smith, D. G. & Fendrick, A. M. Approval times for new drugs: does the source of funding for FDA staff matter? Health Affairs – Web Exclusive 17 December W3-618–W3-624, < http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w3.618v1 > (2003). A recent analysis of the effects of size and source of funding on FDA approval times.

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