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                Oncology Center of Excellence

Oncology Center of Excellence

                        Who We Are - Oncology Center of Excellence
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          Oncology Center of Excellence
          Oncology Regulatory AffairsOncology Center of Excellence Oncology Regulatory Affairs
  
  	
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    PrintOncology Regulatory Affairs in the Oncology Center of Excellence (OCE) collaborates with CDER, CBER, and CDRH to develop and execute an integrated regulatory approach to enhance the cross-center coordination of oncology product clinical review. The focus of Oncology Regulatory Affairs is the following:

Develop and implement procedures that affect the regulatory review of medical oncology products across centers.
	Interact with colleagues in CDRH, CDER, and CBER to allow for a more coordinated review of products undergoing review by OCE.
	Hold internal-facing meetings that allow for OCE policy development.
	Provide a forum for oncology Regulatory Affairs to exchange ideas, streamline regulatory review processes and develop regulatory skills in resolving complex regulatory issues.OCE Pilot Programs

Oncology Center of Excellence Assessment Aid Pilot Project
	Oncology Center of Excellence Real-Time Oncology Review Pilot Program
	Project Facilitate

                                                                                  Content current as of:
      05/29/2019Oncology Center of Excellence

          
                        Who We Are - Oncology Center of Excellence
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