Zdrowie i gospodarka · 07/07/2014
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 guidance for industry entitled "Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention." The purpose of the guidance is to assist sponsors in the development of drugs for the treatment or prevention of neglected tropical diseases (NTDs). This guidance represents the FDA's current thinking regarding drug development for the treatment or prevention of NTDs, including clinical trial designs and internal review standards to support approval of drugs. This guidance finalizes the draft guidance issued August 24, 2011.