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Zdrowie i gospodarka · 24.08.2011

Draft Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention." The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment or prevention of neglected diseases of the developing world. Specifically, this guidance addresses FDA's current thinking regarding the overall drug development program for the treatment or prevention of neglected tropical diseases (NTDs), including clinical trial designs and internal review standards to support approval of drugs.

Source: Federal Register — Health and Human ServicesOpen original release →