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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FDA's Oncology Center Of Excellence On Equal Terms With CDER In New Org Chart
While OCE has a lofty status, it has yet to gain a large cadre of staff.
Multiple ‘Centers of Excellence’ At FDA Could Create Review Inefficiencies – Jenkins
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.
Multiple ‘Centers of Excellence’ At US FDA Could Create Review Inefficiencies – Jenkins
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.