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FDA Warning To Episciences: A Reassertion Of Controversial IND Guidance?

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.

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