The European Medicines Agency is seeking feedback on a modernized version of a 19-year-old guideline on good clinical practice (GCP) that has been updated to factor in improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting1,2.
The European Medicines Agency is seeking feedback on a modernized version of a 19-year-old guideline on good clinical practice (GCP) that has been updated to factor in improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting1,2.
The update is in the form of an addendum to the International Conference on Harmonisation E6 (R2) guideline on GCP,...
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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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