European co-legislators have reached a compromise on the text of the European Health Data Space that will see the controversial opt-out mechanism included in the framework – but with some limitations.
A provisional political agreement on the creation of the European Health Data Space (EHDS) has been reached two days after the European Parliament, the European Commission and the Council of the EU announced they had failed to agree on certain aspects of the new regulation during their last round of negotiations.
All three entities issued statements announcing the provisional agreement during the early hours of 15 March, following a final round...
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A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
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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