Extending an OTC brand name to a product with a different active ingredient and indication creates a margin for error in the marketplace, FDA says. Recommendations include best practices to help minimize name-related medication errors and a framework FDA uses in evaluating proposed propriety names.
Post-market surveillance of medication errors showing that consumers confuse nonprescription drug brands with Rx drugs has prompted a draft guidance from the US Food and Drug Administration on developing OTC brand names.
The document, made available along with a separate draft guidance on naming Rx drugs, is intended “to help ensure that...
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.
