Covid-19 roundup: FDA has finally posted discussion items for tomorrow's adcomm; AstraZeneca could soon resume US vaccine trials
It may have come a day late, but the FDA has finally posted the discussion items that its outside experts will review during tomorrow’s adcomm on the new wave of Covid-19 vaccines now in the clinic.
There are no specific vaccines or data to discuss. Instead, the agency wants feedback on its overall approach. And they’re willing to go late into the evening to get it.
Here’s the rundown:
1. Please discuss FDA’s approach to safety and effectiveness data as outlined in the respective guidance documents.
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