The European Commission is inviting stakeholder feedback on recommendations to help implement several key aspects of the new EU Clinical Trials Regulation, including how to apply a risk proportionate approach for the design and conduct of trials, and how to present a summary of clinical trial results to laypersons1.
The European Commission is inviting stakeholder feedback on recommendations to help implement several key aspects of the new EU Clinical Trials Regulation, including how to apply a risk proportionate approach for the design and conduct of trials, and how to present a summary of clinical trial results to laypersons1.
It is also seeking feedback on a revised definition of an investigational medicinal product (IMP) and on recommendations regarding ethical...
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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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