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The first Complete Response Letter, in which the regulator cited manufacturing issues, came in 2017, and the FDA issued a second CRL in March 2022, flagging signals of AKI

Titles Associate Professor of Emergency Medicine Associate Director of Pediatric Programs, Yale Program in Addiction Medicine Associate Professor on Term, Chronic Disease Epidemiology Education & Training MHSYale School of Medicine, Health Services Research (2012) Postdoctoral FellowYale School of Medicine (2012) Chief ResidentChildren's Strong Hospital, Rochester, New York (2009) ResidencyUniversity of Rochester Golisano Children Hospital (2008) MDUniv of Rochester School of Medicine & Dentistry (2005) BAYale University (2000) Additional Information AB of Preventive Medicine, Addiction Medicine (2018) American Academy of Pediatrics (2018 - Present): Program Planning Committee, American Academy of Pediatrics 2019 National Conference and Exhibition Pediatrics for the 21st Century American Academy of Pediatrics (2016 - Present): Member, Committee on Substance Use and Prevention Academic Pediatric Association (2013 - 2015): Co-Chair, Pediatric Tobacco Issues Special Interest Group Wei S, Van S, Shia C, Gancz M, Camenga D , Aneni K, Marks A, Hieftje K

BioFactors 23:151162

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