FDA Warning To Episciences: A Reassertion Of Controversial IND Guidance?
This article was originally published in The Rose Sheet
Executive Summary
In final agency guidance released Oct. 30, FDA held that clinical studies evaluating products' drug-like effects require Investigational New Drug go-ahead even if the items ultimately will be marketed as cosmetics, a position that industry argued is an unlawful reinterpretation of statutory definitions. FDA's Dec. 2 warning letter to Episciences could be read as an affirmation of the agency's shifting regulatory stance.