FDA final guidance maintains limit on secondary endpoints allowed for trials, which could dissuade some investment in research for NDAs for smoking cessation products. NRT developers could find more room for novel product proposals from changes to some phrasing.
The US Food and Drug Administration’s final guidance on clinical trials for smoking cessation or related indications largely mirrors the draft industry stakeholders described as leaving little room for approvals of novel NRTs, though changes to some phrasing in the document could offer some relief.
The Center for Drug Evaluation and Research’s guidance announced on 28 April reiterates its expectation for multiple clinical trials...
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.
Children with ADHD often struggle with bedtime due to restless minds, difficulty winding down, and heightened sensitivity to nighttime distractions. This article explores the reasons behind these sleep challenges and offers practical solutions.
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.”
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.”
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.
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.
