FDA Genomics Guidance, Demographics Database To Improve Gender Analysis
Electronic clinical trial databases under development at FDA's Office of Women's Health will help sponsors design trials that account for gender and other demographic differences among patients, FDA Commissioner McClellan said
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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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