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Emotional Backdrop Smolders As FDA Reviews Smoking Cessation Category

Executive Summary

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.

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FDA Helps E-Cigarettes Navigate NDA Process With Nonclinical Tests Guidance

Commissioner Gottlieb highlights the first of two draft guidances US FDA will publish on developing "novel, inhaled nicotine replacement therapies that could be submitted to the FDA for approval as new drugs, similar to current" OTC  nicotine replacement therapies. FDA has had a contentious history with manufacturers of electronic nicotine devices, but officials have said the products are eligible for review as NRTs through the NDA process.

FDA Helps E-Cigarettes Navigate NDA Process With Nonclinical Tests Guidance

Commissioner Gottlieb highlights the first of two draft guidances US FDA will publish on developing "novel, inhaled nicotine replacement therapies that could be submitted to the FDA for approval as new drugs, similar to current" OTC  nicotine replacement therapies. FDA has had a contentious history with manufacturers of electronic nicotine devices, but officials have said the products are eligible for review as NRTs through the NDA process.

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