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.
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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.
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.
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.