Coronavirus Update: As Trump Leaves Hospital, White House Blocks FDA Vaccines Guidance
Industry Calls For Documents To Be Released
As the clock ticks down to the US election day on 3 November, President Trump maintains that the first COVID-19 vaccine emergency use approval is imminent. Meanwhile, Fujifilm Toyama's Avigan is near to Japanese approval.
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The political spotlight on the Food & Drug Administration during the COVID-19 pandemic has renewed the long-standing debate as to whether FDA should be made an independent, Cabinet-level federal agency and freed from direct HHS oversight.
Company may have violated FDA’s preapproval promotion restrictions by discussing compassionate use option with Joe Biden’s team and by publicizing it on TV, highlighting the fine line between making the general public aware of expanded access and touting an investigational product as useful for a particular illness.
CBER director said that all the manufacturing data may not be available, but the safety and efficacy data needed for a BLA are expected before an emergency use authorization is granted.