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Proposed Sunscreen Rule, Final MUsT Guidance Jumpstart Next-Gen UV Filter Discussions

 
• By Lauren Nardella

CDER agrees to protect DSMs confidential business information by redacting most correspondence but says general meeting minutes will be made public. To address TEA sponsors' concerns about disclosing proprietary information, "in some situations FDA may hold private meetings with sponsors who request them without subsequently disclosing proprietary information," CDER Division of Nonprescription Drug Products responds to DSM request.

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Four years after the US Food and Drug Administration said data was insufficient to support the safety of bemotrizinol for inclusion in the OTC sunscreen drug monograph, the agency is meeting with ingredient supplier DSM Nutritional Products to discuss the firm's time and extent application for the UV filter.

The Royal DSM NV business requested a non-public meeting and sought the agency’s assurance of confidentiality in January....

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