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Multiple ‘Centers of Excellence’ At FDA Could Create Review Inefficiencies – Jenkins

 
• By Kate Rawson

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.

US FDA's cross-cutting Oncology “Center of Excellence” may be an efficient way to review new cancer treatments, but it is not a model that should be replicated for every therapeutic category across the agency, Office of New Drugs Director John Jenkins said during an exit-interview podcast ahead of his planned departure from the agency on Jan. 6.

“There is a lot of history behind how FDA is organized, and there is some rationale about how FDA is organized around products,” Jenkins said

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