How is receiving FDA approval for a NDA different than meeting the requirements of the FDA Tentative Final Monograph for Topical Antimicrobial Drug Products for Over-the-Counter Human use?
A. When seeking FDA approval for an over-the-counter antiseptic, all manufacturers of chlorhexidine-based solutions are required to submit a New Drug Application (NDA). The review of a NDA by FDA includes evaluation of clinical, manufacturing and labeling information to assure the product is safe and effective. Alcohol and iodophors were identified by FDA as “Generally Recognized As Safe and Effective” (GRASE) and are included in the Tentative Final Monograph from the FDA. As a result, manufacturers of alcohol, iodophors, and iodine-based solutions can market products without submitting efficacy and safety data and product labeling to the FDA for review prior to marketing and selling their products.
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