U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. FDA Organization
  4. Oncology Center of Excellence
  5. Project Orbis
  1. Oncology Center of Excellence

Project Orbis

A framework for concurrent submission and review of oncology products

Project Orbis

The FDA Oncology Center of Excellence (OCE) initiated Project Orbis in May 2019 to provide a framework for concurrent submission and review of oncology products among international partners.

Collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions, regardless of whether the product has received FDA approval. Pivotal clinical trials in oncology are commonly conducted internationally and these global trials are increasingly important for investigating the safety and effectiveness of cancer drugs for approval in the United States. Future drug development may benefit by establishing a greater uniformity of new global standards of treatment, leading to the optimal design of these important trials.

Since its inception, Project Orbis has received many oncology marketing applications and led to the approval of numerous oncology drugs for patients across the world. For more information, please refer to the Project Orbis approval report.

Learn more about Project Orbis

Additional Information

Contact Information

For additional questions please contact [email protected]


Back to Top