NRT Harm Reduction Indications Need Fast-Track Evaluation – Experts
This article was originally published in The Tan Sheet
Executive Summary
FDA should expedite moving NRT claims from a smoking cessation to a harm reduction framework, experts and stakeholders say. At a public hearing, the agency examined expanded indications for the drugs and the challenges FDA faces with two centers that intersect in the tobacco and cessation space.
You may also be interested in...
Tobacco Investment Means E-Cigarette Growth, But Drug Path Raises Questions
Stakeholders discussed electronic cigarettes at an FDA public hearing on smoking cessation, reflecting big tobacco’s buy-in to the market. Firms appear to have a choice between remaining in tobacco’s regulatory space, or following the costly, potentially unclear route to an NDA.
FDA Delves Into Broader Smoking Cessation Approach
FDA’s questions for comments in a notice for a public hearing on smoking cessation approaches suggest a willingness to take an expanded approach to nicotine replacement therapy approvals and indications. Discussion topics include fast-track and accelerated approval authorities for NRTs and extended use of the products.
Ultrahuman Expands Wearable Medtech Production Into US After $35M Funding Round
Firm operating in London, India and United Arab Emirates says its “Ultra Factory” will open in Indiana within the next six months with end-to-end production based on its operational facility in India.