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.
You may also be interested in...
Cures 2.0 Would Mandate More FDA Centers of Excellence But Oncology-Style Funding Gaps Could Doom Plan
The two new intercenter institutes, one to focus on a common group of diseases and the other on rare diseases, appear to be unfunded mandates, which could hinder the agency’s ability to get them up and running.
Commissioner Gottlieb says new centers would follow template of Oncology Center of Excellence.
While OCE has a lofty status, it has yet to gain a large cadre of staff.