FDA warning letter "was a complete surprise to us, especially as we had been advising FDA of our marketing of the CRONaxal product, in writing, for approximately three years as part of our 'orphan drug designation' for glial tumors requirement," says Terra Biological CEO Alan Cook. The firm received an orphan drug designation for oxaloacetate as a treatment for gliomas in 2012.
Terra Biological LLC had an orphan drug designation for oxaloacetate and a pre-investigational new drug meeting with FDA before it received a warning letter because it didn't have the agency's approval for the ingredient as a medical food.
The San Diego firm also had exhibitions at anti-aging and regenerative medicine conferences promoting its oxaloacetate-containing CRONaxal product for treatment...
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.
