Drug Similarities Provide Evidence Latitude, Temple Says; Diovan Example?
Pharmacologic similarity between compounds gives FDA greater latitude in the amount and type of data required for approval, Office of Medical Policy Director Robert Temple indicated during an Aug. 3 interview with "The Pink Sheet.
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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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