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New FDA Initiatives: Project Orbis and Real-Time Oncology Review

The U.S. Food and Drug Administration (FDA) recently announced two exciting and innovative initiatives from FDA’s Oncology Center of Excellence: Project Orbis and Real-Time Oncology Review (RTOR) Pilot Program.

Project Orbis

Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), will provide a framework for concurrent submission and review of oncology products between international partners. The Project’s objective is to 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.

Please click here to read more about Project Orbis on Synchrogenix’s blog.

Real-Time Oncology Review

The Oncology Center of Excellence Real-Time Oncology Review (RTOR) announced a pilot program with aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible. As part of this pilot, FDA will accept an early package submission that includes complete SDTM datasets and top line efficacy tables/figures followed by a completed supplemental New Drug Application (sNDA) and supplemental Biologic License Application (sBLA). For the pilot program, multiple sNDA and sBLA submissions will be selected from each clinical division.

Please click here to read more about Real-Time Oncology Review, including the criteria that submissions should meet in order to be considered for the RTOR pilot.

About the author

Robert Labriola
By: Robert Labriola

Rob has over 25 years of experience in regulatory submissions. He has involvement in the production of electronic regulatory submissions to numerous health agencies, at all roles and leadership levels. Rob has been with Certara’s Synchrogenix division for 5 years where he heads up the regulatory operations team.

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