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

This article was originally published in The Pink Sheet & The Rose Sheet

Executive Summary

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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