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NDAC Input Sought On Sunscreen Ingredient Data Necessary For Approval

This article was originally published in The Tan Sheet

Executive Summary

FDA’s Nonprescription Drugs Advisory Committee will meet Sept. 4-5 to discuss the scope and safety of testing necessary for OTC sunscreen ingredients. The announcement comes after FDA earlier this year rejected time and extent applications to add new sunscreen actives to the OTC monograph.

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All OTC Ingredient TEAs Get Review Deadlines In Senate Draft Bill

Senate HELP committee leaders release a draft bill for discussion that builds on the Sunscreen Innovation Act and its proposed deadlines for FDA review of sunscreen TEA applications, adding provisions that would require FDA to set “reasonable” review deadlines for all OTC ingredient TEAs.

All OTC Ingredient TEAs Get Review Deadlines In Senate Draft Bill

Senate HELP Committee leaders’ draft bill expands on changes in the House’s Sunscreen Innovation Act by requiring deadlines for FDA review of all OTC ingredient TEAs. Chairman Harkin and other HELP members propose setting “reasonable” deadlines for TEA reviews.

All OTC Ingredient TEAs Get Review Deadlines In Senate Draft Bill

Senate HELP Committee leaders’ draft bill expands on changes in the House’s Sunscreen Innovation Act by requiring deadlines for FDA review of all OTC ingredient TEAs. Chairman Harkin and other HELP members propose setting “reasonable” deadlines for TEA reviews.

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