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FDA Week - 08/10/2018

FDA Seeks To Spur Approval Of E-Cigs As OTC Tobacco-Cessation Drugs

August 09, 2018
FDA released the first of what will be two draft guidances aimed at facilitating the development of orally inhaled nicotine-cessation products, like e-cigarettes and other electronic nicotine delivery systems (ENDS), that would go through FDA's approval process for nonprescription drug products sold over-the-counter, instead of being approved by the tobacco center. The guidance, "Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Product," published Friday (Aug. 3), is intended to support the development of novel inhaled nicotine replacement therapies that could go...


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