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Guidance Underscores FDA Practice Of Letting TEAs Steep

This article was originally published in The Tan Sheet

Executive Summary

The viability of time and extent applications as a route to market for new OTC ingredients continues to wane in light of new final guidance on the process.

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FDA Encourages Novel Switch Ideas, Though NSURE Remains Unsure

Rx-to-OTC switch sponsors should not wait for FDA to act on NSURE before proposing innovative switch solutions, because reviewers are open to discussing ideas now, an agency official says. Some experts predict the new switch paradigm will not yield concrete regulatory changes, and are promoting other ways to expand OTC access.

FDA Encourages Novel Switch Ideas, Though NSURE Remains Unsure

Rx-to-OTC switch sponsors should not wait for FDA to act on NSURE before proposing innovative switch solutions, because reviewers are open to discussing ideas now, an agency official says. Some experts predict the new switch paradigm will not yield concrete regulatory changes, and are promoting other ways to expand OTC access.

Sunscreen Group Suggests User Fees To Expedite Ingredient Reviews

The Public Access to SunScreens Coalition will recommend a user fee program to improve FDA’s work on TEAs for OTC ingredients. “Despite a number of OTC applications waiting for approval for several years, FDA has not completed the review of applications for any new sunscreen components,” PASS says.

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