Company News, Regulations

FDA Issues Sunscreen Guidance

Even more onerous requirements for industry, say experts.

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By: Christine Esposito

Editor-in-Chief

On November 22, The US Food and Drug Administration (FDA) published “Nonprescription Sunscreen Drug Products — Safety and Effectiveness Data – Guidance for Industry,” as required by the Sunscreen Innovation Act (Public Law 113 – 195). But industry experts were less than pleased with the guidance.  “From my initial reading of the draft guidance, the FDA is moving full-throttle with treating sunscreens as drugs and is expecting the full complement of drug tests that a...

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