Initial product approvals will kick off a process that an FY23 spending bill provision establishes for the pharmaceutical industry to build on prior knowledge from manufacturing platform technologies. But the FDA can only designate platforms that really will expedite the development and review of new drugs and biologics.
Final statutory language enacted 29 December outlines how the US Food and Drug Administration must consider requests to designate platform technologies like nucleic acid sequences and viral vectors for expedited development and review of new drugs and biologics.
The provision for building upon prior platform knowledge comes amid a proliferation of biopharmaceutical platform technologies for vaccines, cell therapies,...
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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.
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.’
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.
