Oncology Center of Excellence
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Twitter: FDAOncology • Email: [email protected]
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, read the OCE Director's Message.
SAVE THE DATE: 2022 SPRING EVENTS
REGISTRATION FOR JUNE 16 AND 29 EVENTS AVAILABLE SOON
Getting the Dose Right:
Optimizing Dose Selection: Strategies
in Oncology (click on image to register)
Oncology Center of Excellence
& ASCO Workshop
2 Sessions 1:00 - 4:45pm ET Virtual
Oncology Center of Excellence Presents
Conversations on Cancer
National Black Family Cancer Awareness Week: Engaging the Generations
Oncology Center of Excellence Presents
7th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop Keeping an “open” mind: Patient-reported outcomes in
open-label trials
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OCE Guidances – OCE-led FDA guidance documents on oncology topics
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Project Community – empowering patients with cancer, survivors, advocates and consumers
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Conversations on Cancer – OCE’s public panel discussion series, making cancer personal
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National Black Family Cancer Awareness Week – #BlackFamCan social media toolkit
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A Message to Patients With Cancer and Health Care Providers About COVID-1
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Project Socrates – an educational network for oncology product development
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Project Livin' Label – labeling unfolded, knowledge released
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Fellows Program – OCE's educational program for oncology fellows
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Summer Scholars – virtual program for high-school students
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Project Facilitate – assisting oncology providers with expanded access requests
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Project Renewal – labeling updates for older oncology products
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Drug Information Soundcast in Clinical Oncology – short podcasts on oncology product approvals
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Who We Are – Oncology Center of Excellence
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Oncology Regulatory Affairs – cross-center coordination of oncology product clinical review
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Advancing Oncology Decentralized Trials – learning from COVID-19 trial datasets
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Electronic Case Report Form Initiative – COVID-19-related data elements
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Information for Sponsors – submissions to OOD
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Project Point/Counterpoint – increasing transparency of viewpoints for the oncologic drugs advisory committee
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Project Confirm – promoting the transparency of accelerated approval for oncology indications
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Project Orbis – concurrent submission and review of oncology products among international partners.
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Patient-Focused Drug Development Program – patient outcomes research in cancer populations
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Pediatric Oncology Program – promoting development of drugs and biologics to treat cancer in children
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Oncology Real World Evidence Program – fostering science and collaboration to translate real world data into real world evidence
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Rare Cancers Program – to promote the development of safe and effective new drugs and biologics to treat patients with rare cancers.
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OCE Scientific Collaborative – applied research collaborations
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Project Catalyst – fostering early-stage product innovation
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Oncology Regulatory Expertise and Early guidance (OREEG) – product-type advice to inform drug development decisions
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Project Equity – generating Evidence for diverse populations in oncology
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Project Optimus – is an initiative to reform the dose optimization and dose selection paradigm in oncology drug development
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Project Significant – promotes collaboration and engagement among diverse stake holders to further the design and analysis of cancer clinical trials with the goal to advance cancer therapies
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Project Silver – improving the evidence base for the treatment of older adults with cancer
OCE Featured Projects
Project Socrates
The goal of Project Socrates is to build an educational network bridging the OCE and the public, focusing on regulatory policy and science.
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
Project Optimus is an initiative to reform the dose optimization and dose selection paradigm in oncology drug development.
OCE Summer Scholars
The FDA OCE Summer Scholars Program is designed to introduce high school students with an interest in STEM (science, technology, engineering, or mathematics) to the cancer drug development process.