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FDA Should Strike Cosmetics From IND Guidance – Industry Counsel

This article was originally published in The Rose Sheet

Executive Summary

By misstating elements of the U.S. Food, Drug and Cosmetic Act, FDA’s guidance on Investigational New Drug applications is in violation of the law, the Personal Care Products Council’s legal head says. FDA surprised stakeholders by including IND requirements for cosmetics in a final guidance released in late 2013, subsequently opening the section up for comments, which were due April 7.

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