What Does AERS Mean? FDA Takes A Close Look At Spontaneous Reporting
Amid a flurry of recent drug safety initiatives, FDA is not losing sight of the importance of spontaneous adverse event reporting. In fact, the agency is taking steps to evaluate and improve its passive surveillance system, which it expects to remain the cornerstone of its drug safety oversight
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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