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FDA 'May Hold Private Meetings' Offer Eases Sunscreen Monograph Tension

 
• By Malcolm Spicer

Proposed final sunscreen monograph published in February provided more clarity for TEA sponsors to engage with agency, but May publication of final guidance on MUsT for topically applied ingredients for OTC drug monograph could motivate TEA sponsors for sunscreen and other topical active ingredients to push their proposals forward.

Private or Public - Traffic sign with two options - services and companies owned by state or private businessman. Socialist / Capitalist question of privatization, school system, health service - Image

Long-stalled proposals for topical drug additions to the US Food and Drug Administration's OTC monograph could begin making progress as the agency offers private meetings with sponsors on details of their maximal usage trials (MUsT).

A proposed final sunscreen monograph published in February provided parameters for sponsors' work on time and extent applications, but the agency's publication in May of a final guidance on MUsT for topically applied ingredients for the OTC drug monograph could motivate TEA

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