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Home » FDA Issues Draft Guidance on Electronic Submission of OTC Monographs
FDA Issues Draft Guidance on Electronic Submission of OTC Monographs
Following up on a provision of the CARES (Coronavirus Aid, Relief and Economic Security) Act on the regulation of over-the-counter (OTC) monograph drugs, the FDA has issued draft guidance on how submitters should send OTC monographs requests (OMOR) electronically prior to marketing a drug.