Oncology Center of Excellence
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.
- Who We Are – Oncology Center of Excellence
- Information for Sponsors – Submissions to the Office of Oncologic Diseases
To learn more about the Oncology Center of Excellence, please check out our OCE Annual Reports.
Upcoming OCE Meetings and Workshops
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- Withdrawn | Cancer Accelerated Approvals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 approvals
Oncology Guidance – OCE-led FDA guidance documents on oncology topics
OCE Programs and Projects Overview – A Comprehensive List
Careers in Oncology/Hematology
Project Facilitate – Assisting oncology providers with expanded access requests
Project Renewal – Labeling updates for older oncology products
Project 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
Oncology Regulatory Affairs and Policy 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 indications
Oncology Real World Evidence Program – Fostering science and collaboration to translate real world data into real world evidence
Patient-Focused Drug Development Program – Patient outcomes research in cancer populations
Pediatric Oncology Program – Promoting the development of drugs and biologics to treat cancer in children
Rare Cancers Program – Promoting the development of safe and effective new drugs and biologics to treat patients with rare cancers.
Cancer in Older Adults Program – Improving outcomes for older adults with cancer through engagement and research.
Project Orbis – Concurrent submission and review of oncology products among international partners.
Project Asha – Collaboration to increase cancer clinical trial access in India
Project Endpoint – Advancing the use of endpoints in oncology drug development
Project FrontRunner – Advancing Development of Oncology Therapies to the Early Clinical Setting
Project Optimus – Reforming the dose optimization and dose selection paradigm in oncology drug development
Project Catalyst – Fostering early-stage product innovation
- Oncology Regulatory Expertise and Early guidance (OREEG) – Providing product-type advice to inform drug development decisions
Project 5 in 5 crowdsourcing 5 clinically relevant questions for 5 pragmatic trials
Project Pragmatica – Advancing evidence generation for approved oncology medical products
OCE Scientific Collaborative – Applied research collaborations
- OCE Scientific Interest Areas
- OCE-Funded Active Extramural Research Projects
- FDA Broad Agency Announcement: Frequently Asked Questions for Oncology Researchers
Project Significant – Collaboration and engagement among diverse stake holders to further design and analysis of cancer clinical trials
Featured Projects and Events
Project Facilitate
Project Facilitate is a single point of contact call and information center created to help oncology healthcare providers or regulatory professionals submit an Expanded Access Request for an individual patient with cancer through FDA's Expanded Access Program.
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.
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.
Project Optimus
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.