FDA Wants Fast Approval For Cosmetic, Supplement Perceptions Survey
FDA is seeking public comment,with 10 April deadline, on proposal to create a collection of information entitled "Generic Clearance for Qualitative Data to Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed."
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The majority of over-the-counter hand sanitizers and wipes on the US market rely on ethyl alcohol, one of three active ingredients for which final rulemaking has been deferred to allow industry to generate additional safety and effectiveness data. FDA's final rule, released April 11, completes a series of related actions pertaining to OTC antiseptic drug products.
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.
With Pataday Once Daily Relief (0.2% olopatadine) and Twice Daily (0.1%), Alcon adds allergy treatment to its lineup of OTC drops indicated for dry eye and redness. “Obviously, eye allergy will become a much bigger part of the portfolio for us,” says US vision care GM Sean Clark.