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European psychiatry : the journal of the Association of European Psychiatrists, 30(1), 137144

27 Most recently, on August 3, 2018, FDAs CDER issued a draft guidance entitled, Nonclinical Testing of Orally Inhaled Nicotine Containing Drug Products.28 The guidance provides sponsors of NDAs with recommendations on the nonclinical information necessary to support development and approval for orally inhaled nicotine-containing products