Import Safety Legislation: Generic Firms Could Accept Fees, Not Delays
FDA's decision to invoke its Application Integrity Policy with Ranbaxy emphasizes the political risks that the generic industry faces as the debate on import safety returns the fore in Congress
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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