Hundreds of foreign OTC drug firms marketing products in US had not been inspected for GMP compliance before FDA Safety and Innovation Act of 2012 pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and January 2018, 25% received "official action indicated" inspection results, prompting warning letters and import alerts.
There's a reason for a drastic increase in FDA warning letters to OTC drug manufacturers, and it’s not that the number of firms providing nonprescription remedies in the US has jumped.
Hundreds of foreign firms that make OTC drugs marketed in the US had not been inspected for good manufacturing practices...
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.
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.
This HBW Insight series profiles regulatory affairs specialists working in or supporting the consumer health and beauty product industries. In this installment, we speak to Kenvue's Kevin Whelan.
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.
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.
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.
