FDA: Guidance for Industry: Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention
“The purpose of this guidance is to assist sponsors in the development of drugs for the treatment or prevention of neglected tropical diseases (NTDs) of the developing world. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall drug development program for the treatment or prevention of NTDs…” (July 2014).

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