FDA Bill Passes; Congress Adds $225 Million To Industry User Fee Burden
Final FDA reform legislation that cleared Congress adds an additional $225 million to industry's user fee tab over five years, but limits penalties that FDA can assess to enforce its new authorities to mandate labeling changes and postmarket studies
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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