FDA Aims To Bolster Generics' Image With Research, Regulatory Changes
FDA's Office of Generic Drugs is planning a multi-prong approach to boost public confidence in generic drugs, including scientific publications and possible changes in approval guidance, following a series of high-profile concerns raised about the quality of the products
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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