February 5, 2014

The FDA is re-opening comments on portions of its Guidance on Determining if Human Research Studies Require an Investigational New Drug Application. ISAPP intends to file comments reflecting concerns that the current guidance (published in final form September 2013) unduly restricts human research on functional properties of foods and supplements, harming U.S. researchers, consumers and industry. Comments due to the FDA April 7, 2014. Submit comment. See related Latest News posts on September 25, 2013 and November 26, 2013.