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Volume 359:1981-1983 November 6, 2008 Number 19
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Drug Development for Neglected Diseases — The Trouble with FDA Review Vouchers
Aaron S. Kesselheim, M.D., J.D., M.P.H.

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September 2008 marked the beginning of a new federal program intended to promote the development of pharmaceutical products for so-called neglected diseases — infectious diseases that disproportionately affect poor populations in developing countries. Implemented by the Food and Drug Administration (FDA) Amendments Act of 2007, this program will give the sponsor of a drug for a tropical disease a "voucher" entitling the company to expedited FDA review of a new drug application for any other product it makes.1

The need to encourage additional research in this field is clear. Diseases such as tuberculosis, malaria, leishmaniasis, and trypanosomiasis affect millions of . . . [Full Text of this Article]


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Dr. Kesselheim is a patent attorney and an instructor in medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital, Harvard Medical School, Boston.


Related Letters:

FDA Review Vouchers
Moe J., Grabowski H., Ridley D., Kesselheim A. S.
Extract | Full Text | PDF  
N Engl J Med 2009; 360:837-838, Feb 19, 2009. Correspondence

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