FDA: Guidance for Industry Neglected Tropical Diseases (NTD) 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 NTDs of the developing world. Specifically, it
addresses the Food and Drug Administration’s (FDA’s) current thinking regarding
the overall drug development program for the treatment or prevention of NTDs,
including clinical trial designs and internal review standards to support
approval of drugs.
Posted by Tim Sandle
No comments:
Post a Comment
Pharmaceutical Microbiology Resources