FDA May Be Catching Up With FDAAA Workload, Latest Performance Data Suggests
Preliminary FDA data indicate the agency may be catching up with the workload imposed by the FDA Amendments Act, with the agency reporting it could meet 10 of 12 review performance goals for NDAs and BLAs submitted in fiscal 2009.
Learn what's happening at the US FDA. On the go.
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Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
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Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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