Investigator/CRO Financial Disclosure Required By FDA; Feb. Rule Expanded
Investigators must report all financial arrangements with contract research organizations that are acting as primary or joint sponsors of studies, according to an Oct. 26 FDA draft guidance on "Financial Disclosure By Clinical Investigators."
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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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