Issue Date: July 7, 2014
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final
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, 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.
Download the Guidance Document
