FDA's NRT clinical draft guidance is latest piece of its evolving strategy for making available more products to help smokers quit. But FDA maintains requirements that keep approval bar high and its separate draft guidance published in 2018 on nonclinical trials put NRT progress on hold, says Saul Shiffman, an OTC switch consultant with work includes multiple NRT proposals.
An FDA draft guidance clears up details on clinical trials for smoking cessation or related indications, but the agency still leaves plenty of doubt over whether proposals for novel nicotine replacement therapy products, primarily electric nicotine delivery systems, could be approved.
OTC switch consultant Saul Shiffman, whose work includes multiple NRT projects, describes the clinical draft guidance as the latest piece...
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.
To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.
A pilot partnership between the FDA and Canada's Medical Devices Programme has been so successful the two agencies will talk this week about how to expand it.
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.
