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                Oncology Center of Excellence

Oncology Center of Excellence
              
                        Who We Are - Oncology Center of Excellence
          Project Patient Voice


                        OCE Annual Reports
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          Oncology Center of ExcellenceFDA Organization Oncology Center of Excellence

    
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              FDA Commissioner Robert Califf, OCE Director Richard Pazdur and OCE staff gathered outside White Oak Building 22

Connect With Us!

X: @FDAOncology • Email:FDAOncology@fda.hhs.gov

The Oncology Center of Excellence (OCE) was authorized by the 21st Century Cures Act of 2016 and established on January 19, 2017. The Center unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies. The OCE also leads a variety of research and educational outreach projects and programs to advance the development and regulation of medical products for patients with cancer.

To learn more about the Oncology Center of Excellence, please check out our **OCE Annual Reports.**

News, Events & Approvals
	Upcoming Public OCE Meetings

Oncologic Drugs Advisory Committee

Oncology/Hematologic Malignancies Approvals

Ongoing | Cancer Accelerated Approvals
	Verified Clinical Benefit | Cancer Accelerated Approvals
	Withdrawn | Cancer Accelerated Approvals
	Drug Information Soundcast in Clinical Oncology – Short podcasts on oncology product approvalsOncology Guidances – OCE-led FDA guidance documents on oncology topics

OCE Programs and Projects Overview – A Comprehensive List

OCE Publications

Request an OCE Speaker

OCE at ASCO23

Community Resources
	Project Community – Empowering patients with cancer, survivors, advocates and consumers

Conversations on Cancer – OCE’s public panel discussion series, making cancer personal
	National Black Family Cancer Awareness
	Cancer Community ResourcesA Message to Patients With Cancer and Health Care Providers About COVID-19

Healthcare Professional Resources
	Careers in Oncology/Hematology

Project Facilitate– Assisting oncology providers with expanded access requests

Project Renewal – Labeling updates for older oncology products

About Oncology Prescription Drug Labeling
	How Do I Use Prescription Drug Labeling
	Project Renewal FAQProject Socrates – An educational network for oncology product development

OCE PULSE: OCE Oncology News – A monthly newsletter for oncology/hematology fellows and fellowship program directors
	Project Livin' Label– Labeling unfolded, knowledge released
	OCE Regulatory Science Online Lecture Series – On-demand webinars about oncology product development and clinical trials
	Interagency Oncology Task Force Fellowship
	Summer Scholars – High-school student educational program

Regulatory Resources and Programs
	Who We Are – Oncology Center of Excellence

Information for Sponsors – Submissions to the Office of Oncologic Diseases

Project Orbis – Concurrent submission and review of oncology products among international partners.

Oncology Regulatory Affairs Program – Cross-center coordination of oncology product clinical review

Advancing Oncology Decentralized Trials – Learning from COVID-19 trial datasets
	Electronic Case Report Form Initiative – COVID-19-related data elements
	OCE Assessment Aid
	OCE Real-Time Oncology Review
	Project Point/Counterpoint– Increasing transparency of viewpoints for the oncologic drugs advisory committee
	Project Confirm – Promoting the transparency of accelerated approval for oncology indicationsImmuno-Oncology Program

Oncology Cell and Gene Therapy Program

Oncology Real World Evidence Program – Fostering science and collaboration to translate real world data into real world evidence

Oncology Quality, Characterization and Assessment of Real-World Data (QCARD) InitiativePatient-Focused Drug Development Program – Patient outcomes research in cancer populations

Project Patient VoicePediatric Oncology Program– Promoting the development of drugs and biologics to treat cancer in children

Pediatric Oncology Drug ApprovalsPrecision Oncology Program

Rare Cancers Program – Promoting the development of safe and effective new drugs and biologics to treat patients with rare cancers.

Clinical Regulatory Projects
	Project ASIATICA  - Bringing awareness to Asian American, Native Hawaiian, and Other Pacific Islander (AA & NHPI) patients with cancer

Project Endpoint – Advancing the use of endpoints in oncology drug development

Project Equity – Generating evidence for diverse populations in oncology

Project FrontRunner – Advancing Development of New Oncology Therapies to the Early Clinical Setting

Project Optimus – Reforming the dose optimization and dose selection paradigm in oncology drug development

Project Pragmatica – Advancing evidence generation for approved oncology medical products

Project Silver – Improving the evidence base for the treatment of older adults with cancer

Research & Development
	Project Catalyst – Fostering early-stage product innovation

Oncology Regulatory Expertise and Early guidance (OREEG) – Providing product-type advice to inform drug development decisionsOCE Scientific Collaborative – Applied research collaborations

OCE-Funded Active Extramural Research Projects
	FDA Broad Agency Announcement: Frequently Asked Questions for Oncology ResearchersProject Significant – Collaboration and engagement among diverse stake holders to further design and analysis of cancer clinical trials






Featured Projects and Events

Box 2

Conversations on Cancer
Save the Date! Join OCE on January 10, 2024, 2 - 3:30 pm ET, for a panel discussion reviewing 2023 cancer drug approvals. Registration link.

Previous Conversations
November 30, 2023Conversations on Cancer - How Biotech Built a Blockbuster Cancer DrugOctober 19, 2023Conversations on Cancer: Living with Metastatic Breast CancerBox 2

Project Confirm
Project Confirm is an initiative of the FDA Oncology Center of Excellence to promote the transparency of outcomes related to Accelerated Approvals for oncology indications.Box 2

Project Orbis
Project Orbis provides a framework for concurrent submission and review of oncology products among international regulators, which may allow patients with cancer to receive earlier access to products.Box 2

Project Optimus
Is an initiative to reform the dose optimization and dose selection paradigm in oncology drug development.



**OUR MISSION**: The mission of the Oncology Center of Excellence is to achieve patient-centered regulatory decision-making through innovation and collaboration.

**OUR VISION**: We seek to create a unified and collaborative scientific environment to advance the development and regulation of oncology products for patients with cancer.

                                                                                  Content current as of:
      01/01/2024Oncology Center of Excellence
              
          
                        Who We Are - Oncology Center of Excellence
          Project Patient Voice


                        OCE Annual Reports
          Project Community
 
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