US FDA Sets Convalescent Plasma Access Recommendations For Coronavirus Patients
The agency prefers traditional clinical trials be used, but will also allow expanded access or single-patient emergency INDs for the potential coronavirus treatments.
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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.
Director Peter Marks says faster guidance development practices produced well-written documents and may be adopted once the pandemic ends.
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.