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.
Biden administration sets May 11 as end date for public health emergency. CDER has said it will work with sponsors to help them gain approval of COVID therapeutics cleared under emergency use authorizations, but agency will likely not issue a formal transition framework.
OTAT Director Bryan, who has worked at the FDA for more than 20 years, will depart by the end of March as the agency’s cell and gene therapy operations are poised for a major overhaul and a large number of new hires.