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.
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There has been a dearth of guidances from US FDA since Donald Trump's inauguration, but the acting FDA commissioner says that simply reflects the new administration catching up on what's in the pipeline. In a speech at FDLI's annual meeting, Stephen Ostroff struck a positive tone.
Agency is still working to get oncology center of excellence off the ground and has other large pending reorganizations that could take precedence.
Commissioner Califf says review staff reorganization based on disease will go ahead regardless of what other headway VP Biden's initiative makes.