In addition to guidances, the legislation authorizing the monograph program overhaul required the agency to finalize 32 monographs, which it completed in May 2023. (Also see "US OTC Monograph Overhaul Meets DFO Deadline As Stakeholders Make User Fee Introductions" - HBW Insight, 16 May, 2023.)

The first OTC monograph change the agency proposed using its overhauled program outside of finalizing those 32 monographs came in June with a proposed administrative order to change the OTC oral analgesic, antipyretic and antirheumatic monograph to require warnings about skin reactions for acetaminophen-containing oral drugs. (Also see "US Revamped OTC Monograph Program Changes Start With Acetaminophen Skin Reaction Warning" - HBW Insight, 17 June, 2024.)

First Final Guidance For Overhauled US OTC Monograph Program Covers Submitting Proposals

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