Drug sponsors soon will have another hurdle to overcome at advisory committee meetings: significant turnover in the experts asked to consider the approvability of their products. The new policy will help FDA quiet critics of the agency's advisory committee system, but it will also create more noise around the drug approval process.
The look of the Food & Drug Administration’s advisory committees is about to change—literally. Following FDA’s decision to impose tougher conflict of interest criteria on advisory committees, many of the familiar faces serving today may be forced to reconsider their membership.
For drug sponsors, especially those that are filing NDAs this year, the change in advisory committee composition means preparing for...
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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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