US FDA Sets Convalescent Plasma Access Recommendations For Coronavirus Patients
Executive Summary
The agency prefers traditional clinical trials be used, but will also allow expanded access or single-patient emergency INDs for the potential coronavirus treatments.
You may also be interested in...
Preapproval Promotion? US FDA Commissioner Touts ‘Lifesaving’ Investigational Plasma For COVID-19
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.
CBER’s ‘Courageous’ Coronavirus Guidance Strategy May Catch-On
Director Peter Marks says faster guidance development practices produced well-written documents and may be adopted once the pandemic ends.
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.