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To improve public trust, the US Food and Drug Administration (FDA) should be more transparent in publicly disclosing its reviews of safety and effectiveness data leading to Emergency Use Authorization (EUA) of coronavirus disease 2019 (COVID-19) vaccines and treatments, according to a recent report from the US Government Accountability Office (GAO).
In compiling its report, the GAO reviewed federal laws and documents and interviewed officials from the FDA, a public health association, and 9 organizations representing a broad range of frontline health care professionals who are responding to the COVID-19 pandemic.
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The FDA issued a guidance in January 2017 regarding its general recommendations and procedures applicable to all EUAs. It noted that the type and amount of data needed to support an EUA may vary widely, considering that authorization could be granted for many different kinds of medical products. Instead of specifying the minimum number or types of studies required, the guidance stated that it would assess effectiveness data and risk-benefit profiles on a case-by-case basis.
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