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More GRASE Time For 6 OTC Antiseptic Ingredients But 24 Flushed In Final Rule

This article was originally published in The Rose Sheet

Executive Summary

An FDA final rule rejects generally regarded as safe and effective status for 24 OTC monograph antiseptic ingredients regarding products intended for use by health care professionals in hospitals or similar venues. However, six ingredients on which FDA deferred its decision also are used in consumer antiseptic washes, which GRASE decisions pending in separate rulemakings.

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Challenges posed by FDA-advised maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors recently, but a draft guidance from the agency signals that those trials will be expected generally from companies looking to add topical ingredients to OTC drug monographs. CDER details its expectations for studies of ingredients’ absorption potential to inform systemic exposure and overall safety and efficacy conclusions.

Systemic Exposure Data A MUsT For OTC Monograph Sunscreens, Other Topical Drugs In FDA Draft Guidance

Challenges posed by FDA-advised maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors recently, but a draft guidance from the agency signals that those trials will be expected generally from companies looking to add topical ingredients to OTC drug monographs. CDER details its expectations for studies of ingredients’ absorption potential to inform systemic exposure and overall safety and efficacy conclusions.

FDA’s MUsT Draft Guidance Extends Challenge To Wider OTC Drug Industry

It’s known that challenges posed by FDA-advised maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors of late, but new draft guidance from the agency signals that MUsTs will be expected generally from companies looking to add topical ingredients to OTC drug monographs.

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