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All OTC Ingredient TEAs Get Review Deadlines In Senate Draft Bill

This article was originally published in The Tan Sheet

Executive Summary

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

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Senators Optimistic As Sunscreen Bill Heads For HELP Committee Markup

Ahead of a Sept. 17 committee markup of the Senate’s Sunscreen Innovation Act, bill sponsors and stakeholders held a briefing on Capitol Hill to generate support for the legislation, which has already passed in the House. The bill, S. 2141, has 15 co-sponsors and is expected to advance through committee to the Senate floor.

Improving TEA Process Needs More Than Review Deadlines Proposed In Senate

While manufacturers and other stakeholders recommend that FDA eliminate redundant steps and allow more transparency in the TEA process, Senate HELP Committee draft legislation focuses on deadlines for application reviews.

Improving TEA Process Needs More Than Review Deadlines Proposed In Senate

While manufacturers and other stakeholders recommend that FDA eliminate redundant steps and allow more transparency in the TEA process, Senate HELP Committee draft legislation focuses on deadlines for application reviews.

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