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FDA's Final IND Guidance Has Industry On Edge: What Happens Next?

This article was originally published in The Rose Sheet

Executive Summary

It remains to be seen how industry responds to FDA's newly reissued final guidance advising firms to file Investigational New Drug applications for studies exploring would-be cosmetics' structure/function benefits, and how rigorously the agency enforces its position. Attorney Paul Hyman speculates that FDA could rely on INDs to reinforce its authority in the context of warning letters issued to cosmetics firms for unapproved drug claims.

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