The brand name review process is about to get faster and more predictable—but maybe a bit more expensive too.
The Food & Drug Administration is proposing a big change in the way it reviews proprietary brand names. Right now,...
FDA is proposing that drug sponsors assume responsibility for testing proprietary trademarks for potential medication errors before they are reviewed by the agency. That -- along with performance goals tied to user fee dollars -- should help speed up the review of proposed brand names.
The brand name review process is about to get faster and more predictable—but maybe a bit more expensive too.
The Food & Drug Administration is proposing a big change in the way it reviews proprietary brand names. Right now,...
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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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