Final OTC Sunscreen Monograph Postponed, FDA Leadership Confirms

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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The US Food and Drug Administration will not be issuing a final OTC sunscreen drug monograph by 26 November, the deadline set by Congress in the Sunscreen Innovation Act of 2014.

The agency’s Theresa Michele, director of nonprescription drug products at the Center for Drug Evaluation and Research, confirmed the postponement during a 21 November meeting with the Personal Care Products

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