Center for Biologics and Evaluation and Research is to resume normal operations at the beginning of 2023 and will stop prioritizing resources for COVID-19 regulatory work over non-COVID-19 matters.
The US Food and Drug Administration’s Center for Biologics Evaluation and Research anticipates the frenetic pace of work centered on the COVID-19 pandemic to slow down over the next few months. As a result, it plans to resume normal operations at the beginning of 2023 and pay more attention to non-COVID-19 matters.
In a 9 June letter to sponsors, applicants and regulated entities, Christopher Joneckis, CBER’s associate director for review management,...
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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.’
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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