The year-end package of US FDA reforms reflects the impact of one now-retired US Senator: North Carolina’s Richard Burr’s objections helped take out a number of ‘anti-innovation’ provisions – while still securing inclusion of a ‘Platform Technologies’ pathway that might otherwise not have been enacted.
The US Food & Drug Administration will have one year to outline a new “Platform Technologies” pathway for sponsors hoping to streamline development of products that rely on a common backbone (like a vector for gene therapies) to treat different diseases under the year-end spending bill expected to be enacted in the coming days.
The “Platform Technologies” pathway is included in the PREVENT Pandemics Act, which is in turn incorporated in the “Consolidated...
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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.’
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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