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FDA’s own documents reveal agency’s lax, slow, and secretive oversight of clinical research

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Charles PillerThis story was supported by the Science Fund for Investigative Reporting. Please help Science pursue ambitious journalism projects.For nearly a decade, the Food and Drug Administration (FDA) cited osteopath Michael Harris for egregious errors in clinical trials he was overseeing.

Agency inspectors found a litany of problems at Harris’s private firm, Aspen Clinical Research in Orem, Utah, which had contracts to evaluate many drugs, including ones aiming to treat postoperative pain, pediatric schizophrenia, and migraines.

FDA found there were serious lapses in obtaining informed consent from trial volunteers, unqualified staff made medical assessments, and Harris failed to properly report abnormal lab test results.

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United States
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Russia
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Deaths: 237 619
Recovered: 0
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Covid-19.rehab - the latest news concerning the spread of the SARS-CoV-2 coronavirus (formerly 2019-nCoV), as well as the infectious disease that it causes COVID-19, in separate countries and in the world as a whole. Current news on the topic of coronavirus SARS-CoV-2. Quarantine, pandemic 2020, epidemic: what is it, when will it come to end, precautions and how to protect yourself from this disease. The most honest news, no fakes! To keep up with the latest news, stay tuned for updates on the site! Every day we will collect news and statistics on coronavirus from around the world for you to be aware of this topic.

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