Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.
The US Food and Drug Administration stood its ground when confronted recently by trade associations for manufacturers of OTC and Rx drugs over the difficulty of following agency guidance on reducing cancer risk from nitrosamine impurities to acceptable levels.
The agency, however, left an opening for continuing dialogue over possibly further extending compliance deadlines set forth in the September...
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.
In this episode of the Over the Counter podcast, HBW Insight speaks to Kerry's RDA senior manager of immune and joint health, Sonja Nodland, about the opportunity for innovation that postbiotics represent for the consumer health industry.
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.
Height of plaintiff attorney’s argument to present evidence which would prompt speculation by a jury was request to parse research by Kenvue’s lead expert, who coordinated the International Consensus Statement on ADHD by the World Federation of ADHD, where he’s president.
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