Federal Register Proposed rule: FDA is reopening until 9/2, the comment period on the agency's proposal to amend the tentative final monograph for OTC internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include ibuprofen as a generally recognized safe and effective analgesic/antipyretic active ingredient for OTC use and to amend its regulations to include consistent allergy warnings for OTC IAAA drug products containing nonsteroidal antiinflammatory active ingredients. To view this proposed rule, click here.
