After Remdesivir's Emergency Use Authorization, US Gov't Must Now Decide How To Distribute Limited Supply
Gilead's antiviral remdesivir will go to hospitalized severe COVID-19 patients per FDA's EUA. Some cities could receive the medicine with days, but it is not clear how the government will dole out the limited supplies. FDA said it had access to non-public data from a key NIH trial during its EUA review.
You may also be interested in...
HHS Shifts Remdesivir Distribution To Gilead As Supply Crunch Eases
AmerisourceBergen will continue to serve as the sole US distributor of Veklury (remdesivir) through the end of this year and will continue to sell the the COVID-19 treatment directly to hospitals.
Remdesivir’s Path To Orphan Designation Could Be Exploited By Others, Experts Warn
Congress should give FDA more flexibility to administer orphan designations, such as the ability to revoke designations later if the disease prevalence grows beyond the rare disease threshold.
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.