For first time rules for novel switches and OTC hearings aids are parts of “significant regulatory actions” in agency’s plans. Information is added in Unified Agenda items explaining likely benefits and costs from the changes.
The US Food and Drug Administration once again includes in its regulatory agenda update a timeline for publishing a proposed rule to facilitate novel Rx-to-OTC switches. But for the first time the agency includes the change as part of “significant regulatory actions” in its plans.
The agency did the same with its item for a potential final rule on making hearing aids available OTC. For...
Des recherches montrent que l’asthme et le diabète de type 2 (DT2) sont liés au-delà du hasard, partageant des facteurs inflammatoires et métaboliques. Cette association souligne l’importance d’une surveillance accrue et d’une prise en charge adaptée pour prévenir les complications chez les patients
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.
Following Energy and Commerce Health Subcommittee hearing about FDA’s human food and tobacco programs on 10 September, gap between what the trade groups, committee leadership and the FDA each want more of doesn’t appear to be shrinking.
At one year, TikTok Shop conjures the early days of Amazon, representing the ‘Wild West’ of beauty ecommerce, said co-founders of private label and contract manufacturing company KO-Pack at the IBA Cosmetics Convergence Fall 2024 Virtual Symposium, “The Promise and Pitfalls of TikTok Shop.”
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.
In this installment of HBW Insight’s “Inside Regulatory Affairs” series, we hear from Sharee Crumbey and Monica Sharda, regulatory affairs specialists at The Honest Company, about the mounting challenges and rewards of the job.
