Drug Development for Neglected Diseases — The Trouble with FDA Review Vouchers  

Oleh:

Kesselheim, Aaron S.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: The New England Journal of Medicine (keterangan: ada di Proquest) vol. 359 no. 19 (Nov. 2008), page 1981.

Ketersediaan

Perpustakaan FK Nomor Panggil: N08.K.2008.06 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

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 . . .

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