Time For Independent FDA? COVID-19 Political Pressure Reignites Debate
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.
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Everyone but Donald Trump seems happy that the guidance is finally here, with release appearing to be driven by FDA's disclosure of advisory committee materials.
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.
Guidance's release would provide regulatory clarity to scientists and strengthen public confidence in any vaccine authorized by the FDA, trade group says, but Alex Azar tells Congress the controversy over the unpublished document is overblown and making a ‘mountain out of a molehill.'