FDAAA Impact (Year Two): More of Everything
The second year of the FDAAA-era is over, and FDA is using its new drug safety tools (Risk Evaluation and Mitigation Strategies and mandatory post-marketing studies) more often. Not only are more drugs requiring REMS and mandatory trials, the burden of those programs is increasing
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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