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Pharmaceuticals / Regulatory Affairs

FDA to Hold Public Meeting on the Direction of the Oncology Center of Excellence

Dec. 13, 2017
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The FDA will host a public meeting next year to give industry the opportunity to make recommendations for the agency’s Oncology Center of Excellence, which coordinates clinical reviews for cancer products across CDER, CBER and CDRH.

Alongside a public docket, the FDA is seeking stakeholder comments on what they want from the OCE’s structure, function, regulatory purview and activity. The meeting will be held March 15, 2018.

The OCE is the agency’s first disease-centric intercenter institute. FDA Commissioner Scott Gottlieb told lawmakers on Capitol Hill this month that the agency plans to fully stand up and fund the OCE before expanding its model to other disease areas, such as immunology or neurology.

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