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ACI’s Antiseptic Testing Continues Under Specter Of FDA Administrative Order

 
• By Ryan Nelson

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.

Building icon with inscription FDA and flag of The United States over abstract background. - Illustration

While OTC drug review has changed in the US, there continues to be a spirit of collaboration between the US Food and Drug Administration and antiseptic industry stakeholders as testing advances to fill ingredient safety and efficacy data gaps identified under the former OTC monograph system.

According to James Kim, vice president of sciences and regulatory affairs at the American Cleaning Institute, ACI and its members...

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