FDA Seeks Comment On Proposed Orders Under Sunscreen Innovation Act
This article was originally published in The Rose Sheet
Under the Sunscreen Innovation Act enacted in late 2014, FDA’s tentative determinations on time and extent applications for sunscreen ingredients are now deemed proposed orders and must be made available for public comment. The agency seeks input on six insufficient-data letters issued to sunscreen TEA sponsors in 2014, including its latest to BASF regarding bemotrizinol, marketed as Tinosorb S.
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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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