ISAPP files comments with the FDA on their partial stay of sections of their guidance for INDs

June 28, 2016 – ISAPP disagrees with the approach FDA has taken to address their overreach of requiring investigational new drug applications for most human research on foods or supplements in the United States. In response to criticism of their 2014 final guidance, Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application, the FDA filed a partial stay of some requirements for INDs (see Partial Stay and Republication of Guidance). ISAPP considers this action to be insufficient to fully address the problems caused by their guidance, especially as it relates to probiotic research.

See ISAPP’s comments.