The International Conference on Harmonisation is working on establishing general principles on how sponsors can plan and design multi-regional clinical trials so as to facilitate the acceptance of data from such studies by multiple regulatory agencies1,2.
The International Conference on Harmonisation is working on establishing general principles on how sponsors can plan and design multi-regional clinical trials so as to facilitate the acceptance of data from such studies by multiple regulatory agencies1,2.
Conflicting regional requirements on data for multi-regional clinical trials currently lead to duplication of unnecessary clinical trials and delay drug...
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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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