FDA Misses User Fee Goals As Resources Tighten For Application Reviews, SPAs
With the ink of the reauthorized Prescription Drug User Fee Act still drying, FDA is signaling that it may be some time before the agency will consistently meet the performance goals of its user fee program
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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