The FDA and the importance of trust

New England Journal of Medicine

30 September 2020 - As SARS-CoV-2 emerged, the global scientific community first studied the virus at the bench, then took what was learned to the bedside in the hope of helping patients, and later returned to the bench with observations from the bedside.1

Such a process has led to progress in the treatment and prevention of every important disease we have faced, including AIDS, cancer, and diabetes. In the case of SARS-CoV-2, the information we have gathered has increased our understanding of the biology of the virus, the diagnosis of the infection, the nature of the injury it causes, and potential therapies to treat it, but much is still unknown. 

In COVID-19, clinicians at the bedside continue to face an imperfectly understood disease that leads to tragic consequences for too many patients. Under enormous pressure to help patients while doing no harm, clinicians rely on the transparency of the scientific process and on the careful judgment of regulators who base their decisions on the best available scientific understanding of the disease.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation , Vaccine , Standards