US FDA Commissioner says agency will soon offer more clarity on using real-world evidence in drug development, but notes industry needs to take risks of its own.
US FDA Commissioner Scott Gottlieb announced that the agency will be instituting regulatory clarity on the real-world evidence front, but also called on industry to take its chances in using such an approach in drug development.
"This takes a little bit of risk-taking on the part of sponsors who have to do something different in the...
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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.
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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