OTC Monographs@FDA is a publicly accessible repository for proposed, final, and interim final orders for OTC monograph drugs via the new OTC drug review program created by last year’s CARES Act. So far, the agency has posted seven of 32 “deemed” final orders created by the legislation.
For a dizzying journey back into 2020 legislation that overhauled the US Food and Drug Administration’s OTC drug review program, and FDA recordkeeping activities since, look no further than the FDA’s 21 September Federal Register notice on final administrative orders for over-the-counter monographs.
The Coronavirus Aid, Relief and Economic Security (CARES) Act, signed into law in March 2020, converted the FDA’s OTC drug...
Green Pharmaceuticals’ SnoreStop Nasal Spray, previously marketed as “NasoSpray,” still is available even though agency officials on multiple occasions for a month recommended a recall after an April inspection found “gross microbial contamination” in one lot.
Global beauty giant is working to adapt its approach to the prestige market to meet escalating competition, increased points of sale, and more knowledgeable consumers with new shopping habits, CFO Tracey Travis said at the Barclays Global Consumer Staples Conference.
Court order dismisses claims against Perrigo and Joseph Papa, its former CEO, with prejudice. Settlement also bars any claim against plaintiffs and class members, “whether arising under state, federal, common or foreign law,” alleging liability for losses.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
Week after publishing safety alert about OPMS Black Liquid Kratom “linked to serious adverse health effects, including death,” FDA announced market research “to understand and characterize emergent risk/safety and perceived benefits reportedly linked to kratom and psychedelics.” But it withdrew the study 10 days later.
Semi-annual regulatory agenda of non-binding target dates also sets December goal for an NPRM to recognize N-acetyl-L-cysteine as a lawful dietary ingredient. Like IND exemptions rule, item on NAC included for first time in FDA’s list.
