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Health Care law Section Chairs : EricaMallon – AmericanOncologyNetwork & ElizabethScarola – EpsteinBecker
The promise of clinical trials has never been more apparent ( and , publicly scrutinized ) than during the COVID-19 public health emergency . Clinical research has always been subject to the oversight of myriad enforcement bodies ; but recent developments demonstrate that enforcement activity is on the rise . For example , inacountrywhere 425millionamericans placedtheirtrustin clinicaltrialdatawhen receivingaCovid-19 vaccine , clinicaltrials faceenhancedscrutiny .
the Department of Justice demonstrated interest in clinical research oversight with criminal convictions this fall .
DOJ Enforcement In August , U . S . District Judge
Jose E . Martinez in the Southern
District of Florida sentenced two parties ( Eduardo Navarro , 52 , of Miami and Nayade Varona , 50 , of Port St . Lucie ) to prison terms . The defendants ( a nurse practitioner , acting as a sub-investigator and an
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