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# Oncology ‘Excellence’ Center Handling Reviews: Pazdur
- URL: https://www.fdaweb.com/oncology-excellence-center-handling-reviews-pazdur/
- Published: 2017-05-18T12:00:00.000Z
- Updated: 2026-09-14T22:24:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138728

FDA Oncology Center of Excellence (OCE) director **Richard Pazdur** says the Center has begun coordinating clinical review of oncology products. Writing in an online *American Journal of Managed Care* post, Pazdur [says](http://www.ajmc.com/journals/evidence-based-oncology/2017/peer-exchange-spring-2017-oncology-stakeholders-summit/FDA-Oncology-Center-of-Excellence-Moves-Forward-on-Coordinated-Clinical-Reviews-Integrated-Approach-to-the-Clinical-Evaluation-of-Oncology-Products?ref=fdaweb.com) that applications are submitted to CDER, CBER, or CDRH and, if appropriate, OCE forms a clinical review team with experts from the three medical product Centers as needed based on the specific application. The review team only makes recommendations on the clinical portion of the application; the medical product Center looks at all other aspects. The Center opened 1/2017 in response to President **Barack Obama**’s “cancer moonshot” initiative.

“By bridging the various medical product centers of FDA, the OCE is ideally suited to support innovation and address the recognition that multiple treatment and diagnostic options are in the best interest of patients,” Pazdur says. “An important aim of the OCE is to facilitate incorporation of the patient view into regulatory decision making. The OCE’s Patient-Focused Drug Development Program will foster collaboration between FDA, patients, and advocacy groups; nurture research into measurement of the patient experience; and generate science-based recommendations for regulatory policy. An ongoing initiative at the OCE is an effort to modernize and broaden the eligibility criteria for patients enrolling in cancer clinical trials.”