OTC Antiseptic Industry Advancing Work To Show Germ-Killing Ingredients Are GRASE
Notwithstanding issues with contract testing labs and a lull in US FDA communication, the American Cleaning Institute is optimistic about progress to support GRASE decision-making for OTC topical antiseptic products, including pilot maximal usage trial (MUsT) studies and proposed investigations to see if antimicrobial soap reduces MRSA transmission in US military barracks.
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Agency’s recent responses denying three petitions filed in 2001 by US industry trade groups and in 2002 by pharmaceutical ingredient and chemicals firm explain the changes requested can be proposed in “OTC monograph order requests” pathway established in program overhaul.
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The American Cleaning Institute is preparing to submit a healthcare personnel hand wash study to the US FDA pending confidentiality discussions, along with results from a literature review on the topic of antimicrobial resistance. A progress report is due to the agency in October, which could stave off an administrative order under the reformed OTC drug review system.