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.
US FDA suggested potential risk could be managed though a change in the fact sheet, but CDC committee wants more data, which could come within a week or so, to get a better sense of the frequency of the adverse events.
Concept could help sponsors who reach approvability but must wait several years before reference product exclusivity expires.