US FDA COVID-19 Adcom: What Additional Members Are Needed?
Beyond vaccine experts, specialists in medical areas where there might be safety concerns, as well as epidemiologists, could be helpful to aid the FDA in understanding the data in a coronavirus vaccine application.
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US FDA authorization will further boost already-high demand for plasma from individuals recovered from COVID-19 and increase competition for donors, NYU’s Arthur Caplan predicts, but CoVIg-19 Plasma Alliance and Emergent BioSolutions say they do not expect EUA to impact either product supply or enrollment in upcoming randomized trials of their H-Ig products.
Agency commissioner appeals to AMA audience to communicate message that FDA review decisions are based on good science.