FDA Oncology Center Of Excellence Coming, Moonshot Or Not
This article was originally published in The Pink Sheet Daily
Commissioner Califf says review staff reorganization based on disease will go ahead regardless of what other headway VP Biden's initiative makes.
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While OCE has a lofty status, it has yet to gain a large cadre of staff.
In an interview, US FDA’s outgoing head of new drug review cautions against duplicating the agency's Oncology Center of Excellence model across multiple therapeutic areas, advocating for a more "balanced portfolio" in structuring review operations.
FDA’s outgoing head of new drug review cautions against duplicating Oncology ‘Center of Excellence’ model across multiple therapeutic areas, advocating for a more ‘balanced portfolio’ in structuring review operations; other topics during podcast interview include Jenkins’ future plans in drug regulation and one major safety decision that turned out differently than expected.