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

FDA's NRT clinical draft guidance is latest piece of its evolving strategy for making available more products to help smokers quit. But FDA maintains requirements that keep approval bar high and its separate draft guidance published in 2018 on nonclinical trials put NRT progress on hold, says Saul Shiffman, an OTC switch consultant with work includes multiple NRT proposals.

An FDA draft guidance clears up details on clinical trials for smoking cessation or related indications, but the agency still leaves plenty of doubt over whether proposals for novel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OTC switch consultant Saul Shiffman, whose work includes multiple NRT projects, describes the clinical draft guidance as the latest piece...