From EUA To Full Approval: CDER, CBER Still Developing Transition Plans
US FDA drug center is evaluating how to handle the end of the coronavirus public health emergency, which would mean unapproved products would no longer be available, but officials likely have plenty of time to consider options.
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EUA request should also include plan for a sponsor’s active follow-up for safety among individuals given the vaccine under EUA – including assessing deaths, hospitalizations and other clinically significant adverse events – to inform ongoing benefit-risk determinations to support the continued authorization, US FDA says in its finally-released guidance.
The median of two months of follow-up is not absolute, but agency flexibility is limited.
Jeff Shuren, director of the US FDA’s device center, says the agency is drafting a guidance document that will give industry recommendations on how it should handle products granted emergency use authorization during the COVID-19 public health emergency, once it’s over. The guidance will also address already-approved devices that were modified by their makers under enforcement discretion.