Label Comprehension Guidance May Improve Switch Outlook
Final guidance for label comprehension studies replaces several draconian draft recommendations with more flexible "common sense" measures, but drug sponsors may need to conduct significantly larger, more expensive studies and meet more extensively with the agency, experts say
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It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told 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.
