Phase IV Commitments Are Increasingly Delayed, FDA Report Finds
The rate of delayed postmarketing commitments has increased since 2005, according to data provided in FDA's annual "Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies.
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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.
