Convalescent Plasma Decision May Be ‘Week Or Two’ Away, US FDA’s Hahn Says
Commissioner says the agency is reviewing efficacy and safety data, presumably for an emergency use authorization of a product derived from patients who recovered from the virus.
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Clinical trials would have to move outside US if agency issues emergency use authorization for convalescent plasma, NYU prof says; experts disagree on whether the FDA should issue EUA.
Hahn’s communications, which go far beyond the claims a sponsor could make of an investigational product, are raising new concerns about the agency’s ability to serve as a science-based regulator during the coronavirus pandemic. HHS Secretary Alex Azar and NIAID Director Anthony Fauci have also touted the lifesaving nature of plasma donations for COVID-19, even though the treatment is still unproven.
Convalescent plasma, anti-inflammatory agents among those that could be considered for EUAs, Commissioner Hahn says during congressional hearing on the coronavirus response.