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Calls for clearer Agency feedback to industry and a pathway for dispute resolution.
November 21, 2024
By: Christine Esposito
Editor-in-Chief
The American Cleaning Institute (ACI) provided comments to the US Food and Drug Administration (FDA) at the Agency’s Over-The-Counter Monograph Drug User Fee Program (OMUFA) Reauthorization Public Meeting on November 20. The meeting was held at the FDA Headquarters at the White Oak Campus in Silver Spring, MD.Dr. James Kim, ACI SVP, science and regulatory affairs, provided comments regarding the Topical Antiseptics Program, focusing on getting clearer feedback from FDA on GRAS/E expectations, an...
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