FDA Likely To Take Holistic View Of AER Bill Compliance, Expert Says
FDA will likely evaluate a company's compliance with adverse event reporting and record-keeping requirements on a "performance-oriented basis," said Rick Kingston, PharmD, president and senior clinical toxicologist at SafetyCall International, an adverse event call center
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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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