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FDA’s Final Guide On ENDS PMTAs Sparks Backlash From Industry

By Beth Wang
June 11, 2019 at 2:18 PM
FDA finalized guidance on Tuesday (June 11) that details the type of information sponsors of electronic nicotine delivery systems should include in their premarket approval applications. The final guide adheres closely to the 2016 draft version despite industry assertions that FDA lacks authority to enforce several of the recommended requirements. The guidance sparked debate on social media between vaping organizations and former FDA Commissioner Scott Gottlieb, with each blaming the other for hindering productive conversations that could help move the...


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