FDA's use of Risk Evaluation & Mitigation Strategies will require NDA and BLA sponsors to provide more rigorous definitions of patient populations. Former FDA Commissioner Kessler thinks that may break the logjam on approvals.
Former FDA Commissioner David Kessler, MD, sees a way out of the new product drought for pharma in the just-passed Food & Drug Administration Amendments Act of 2007.
While many in industry remember Kessler as the commissioner who led a major assault on off-label use of drugs in...
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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.’
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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