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.
Drug Information Soundcast in Clinical Oncology – Short podcasts on oncology product approvals
Oncology Guidances – OCE-led FDA guidance documents on oncology topics
OCE Programs and Projects Overview – A Comprehensive List
Project Community – Empowering patients with cancer, survivors, advocates and consumers
Conversations on Cancer – OCE’s public panel discussion series, making cancer personal
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
Summer Scholars – High-school student educational program
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
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.
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
Project Catalyst – Fostering early-stage product innovation
Oncology Regulatory Expertise and Early guidance (OREEG) – Providing product-type advice to inform drug development decisions
OCE Scientific Collaborative – Applied research collaborations
Project Significant – Collaboration and engagement among diverse stake holders to further design and analysis of cancer clinical trials
Featured Projects and Events
February 27, 2024: Conversations on Cancer Black History Month Program—Real Talk: Our Stories as Black Oncologists at the FDA. 1-2:30 pm ET. Registration.
March 19, 2024: Conversations on Cancer – ODAC Chronicles - the Past, Present, and Future of Oncology Advisory Committees. 9:30-11 am ET. Registration.
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.