With monographs@FDA portal down, agency moves to NextGen and extends comment period through 27 September for first OTC monograph change it proposed using its overhauled program other than 32 monographs finalizations required in 2020 legislation authorizing overhaul.
If ever a glitch in a Food and Drug Administration program could be attributed to growing pains, the Office of Nonprescription Drug’s problem with its OTC Monographs@FDA portal would be it.
In an 8 August Federal Register notice, the agency extended the comment period through 27 September for the first OTC...
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.
The gut’s microbiome will shape future medical advances, offering personalized therapies and prevention strategies for a wide range of diseases.
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.”
Supergut brand owner Uplifting Results Labs makes Gut Healthy GLP-1 Booster prebiotic fiber mix along with its snack bars and meal-replacement shakes available through GNC. IHerb launches supplements addressing side GLP-1 effects including nausea and pain, loss of muscle mass and changing blood sugar levels.
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.
