Biden COVID-19 Plan Would Grow Domestic Manufacturing Base
The proposal, which would increase capacity for pandemic supplies, is similar to ideas President Trump embraced pre-pandemic.
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So says infectious diseases physician Celine Gounder, who’s a member of the US president-elect’s COVID-19 task force.
More than 5% of participants in J&J’s vaccine trial chose to be unblinded because they were eligible to receive a vaccine that had already gained a US FDA emergency use authorization.
A proposed pilot program would offer for “split submission and review” of some application sections in other disease areas. Discussions also touch on concept of a CDER-CBER RWE committee.