Emergency User Authorization Requirements May Offer FDA Better Window Into Medication Errors
Unlike with traditional approvals, emergency use authorization requires medication error reports to be submitted to the FDA, offering additional insight into why they occur.
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Actemra finally gains an emergency use authorization, Lilly's antibodies withdrawn again amid Delta variant concerns, plus Latin America’s belief in an anti-parasite drug in COVID-19 could soon be punctured.
As distribution of Regeneron’s monoclonal antibody treatment for coronavirus begins, OWS officials worry about provider confusion with Lilly’s product due to differences in preparation and administration.
Cures 2.0 Would Mandate More FDA Centers of Excellence But Oncology-Style Funding Gaps Could Doom Plan
The two new intercenter institutes, one to focus on a common group of diseases and the other on rare diseases, appear to be unfunded mandates, which could hinder the agency’s ability to get them up and running.