Avandia Advisory Cmte. Is FDA's Primary Response To Congressional Pressure
Sponsors will get another look in July at how FDA interprets guidance for assessing the cardiovascular risk of diabetes drugs in clinical trials. The venue will be a meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees
Learn what's happening at the US FDA. On the go.
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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.’
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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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