Wider Options In FDA's NRT Clinical Trial Guidance, Approval Path Still Narrow

An FDA draft guidance clears up details on clinical trials for smoking cessation or related indications, but the agency still leaves plenty of doubt over whether proposals for novel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OTC switch consultant Saul Shiffman, whose work includes multiple NRT projects, describes the clinical draft guidance as the latest piece of FDA's evolving strategy for making available more products indicted to help smokers quit