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A dose-response trend was also present with increasing ORs observed for higher levels of smoking (1-9 cigarettes daily: OR = 1.05, 95% CI: 0.95, 1.17

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27 Most recently, on August 3, 2018, FDAs CDER issued a draft guidance entitled, Nonclinical Testing of Orally Inhaled Nicotine Containing Drug Products.28 The guidance provides sponsors of NDAs with recommendations on the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

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Additional information This article is part of the Topical Collection on Pediatric Allergy and Immunology Rights and permissions About this article Cite this article Makadia, L.D., Roper, P.J., Andrews, J.O