House Energy and Commerce Democrat and Republican members who back monograph reform are co-sponsors of Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, which also includes provisions largely tracking with standalone monograph reform legislation that passed the House in July, including allowing 18-month market exclusivity periods for some ingredients, formulations or indications added to a monograph.
Legislation to overhaul FDA's monograph process for adding OTC drug ingredients and indications got a spark of a chance to pass in 2018 as part a bill on public health security and all-hazards preparedness and response that cleared the House on Dec. 20, a day after it was introduced.
Democrat and Republican members of the House Energy and Commerce Committee who have been key backers of monograph reform legislation...
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.
