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GUIDANCE DOCUMENT

Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention July 2014

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2011-D-0587
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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, as defined in section 524(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including clinical trial designs and internal review standards to support approval of drugs.

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All written comments should be identified with this document's docket number: FDA-2011-D-0587.

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