In the April 4, 2016, Federal Register, FDA issued a proposed rule to amend its nonprescription OTC drug regulations. The proposed rule, if finalized, would supplement the TEA process for OTC drugs by establishing timelines and performance metrics for FDA's review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act. FDA is also proposing other changes to streamline the TEA process. Comments are due June 3, 2016.
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