FDA Broadens Nicotine Therapy Indication Review With Steering Committee Docket
This article was originally published in The Pink Sheet & The Rose Sheet
FDA seeks broader guidance than comments and information submitted at a January public hearing on standards testing and evaluations that could expand the variety of products approved as NRTs The docket is open to "recommend specific topics for direct, collective engagement and consideration by the" steering committee.
You may also be interested in...
State Opioid Prescribing Databases Can Handle US FDA's Needs, Officials Say
Pharma firms might avoid paying for national opioid prescription monitoring database because state systems already talk to each other, although current operations still need some upgrades.
Emotional Backdrop Smolders As FDA Reviews Smoking Cessation Category
FDA asks for comments including evidence needed to show safety and efficacy for novel nicotine replacement therapies, but speakers at recent hearing highlight the public's psychological toll from tobacco-related deaths and the emotional connection smokers have with tobacco and nicotine.
FDA's Nicotine Replacement Standards Review Could Open Door For E-Cigarettes
Latest steps by US FDA targeting tobacco-related health problems are a Nicotine Steering Committee, headed by Commissioner Gottlieb, and a public docket, including a meeting in January, for suggestions on how novel products could be evaluated as safe and effective NRTs.