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Sunscreen Guidances Underscore FDA Standards Aren’t Changing

This article was originally published in The Pink Sheet

Executive Summary

CDER has published guidances, required by the 2014 Sunscreen Innovation Act, on FDA’s process for advisory committees to consider firms’ sunscreen ingredient proposals and on withdrawing pending proposals being considered by the agency.

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Confidentiality Slim, Punctuality Prime In Sunscreen TEA Draft Guidances

CDER’s draft guidances on formatting TEAs, withdrawals of applications and requesting an advisory committee review arrive along with its draft on safety and effectiveness data to determine whether OTC sunscreen active ingredients should be added to the monograph.

Sunscreen TEAs Should Model Applications For Chronic-Use Cutaneous Drugs – FDA

TEAs for UV filters should provide FDA with clinical safety data used to support approval of chronic-use cutaneous drugs and nonclinical testing should focus on potential long-term adverse effects, according to draft guidance required under the Sunscreen Innovation Act. FDA particularly is interested in comments about final formulation safety testing it anticipates requiring under specified monograph conditions.

BASF Asks FDA To Weigh Whole Sunscreen TEAs, Not Separate Parts

The firm’s representatives maintain a “weight-of-evidence” approach comprising repeated dose toxicity, photo-genotoxicity, dermal carcinogenicity and photo-carcinogenicity studies is adequate to establish safety. In public meetings required by the Sunscreen Innovation Act, FDA officials say BASF needs to provide more study data.

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