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Final OTC Sunscreen Monograph Postponed, FDA Leadership Confirms

Executive Summary

The US FDA is still working through more than 20,000 comments on its February proposed rule to establish a final OTC sunscreen drug monograph. Thus, it will not meet the 26 November 2019 deadline set by the Sunscreen Innovation Act of 2014, said Theresa Michele, director of FDA’s nonprescription drug division, during a 21 November public meeting with industry advocates.

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