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FDA Sunscreen GRASE Final Guidance Unchanged From Draft

Guidances on TEA submissions format and on data and other information to show an ingredient is GRASE are changed little from the draft versions and do not discuss comments submitted to the agency on the drafts.

FDA publishes the two remaining guidances required on time and extent applications for sunscreen monograph changes, including the critical discussion of data needed to support generally regarded as safe and effective status.

Like previous guidances also required by the Sunscreen Innovation Act, FDA's guidance documents on format and content of...

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