FDA Cites Long-Term Precedent In Blocking Retail Genetic Screening Plans
A particularly public pre-emptive stance by FDA's in vitro diagnostics oversight office halts Pathway Genomics' plans to start selling genetic screening test sample collection kits out of Walgreens stores, but the office's director stresses the move does not signal any changes to its enforcement policy for laboratory-developed tests
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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