EMEA explains new accelerated assessment procedure
The European Medicines Agency (EMEA) has issued a draft guideline explaining the new accelerated assessment procedure for products of major therapeutic interest that was introduced by Regulation (EC) No 726/20041,2.
Under the regulation, which came fully into effect on 20 November 2005, a company may ask for a product to...
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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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