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What is Project Orbis and is it a Fast-track to Approving Cancer Drugs?

What is Project Orbis and is it a Fast-track to Approving Cancer Drugs?

Serious questions that must be answered...

Hedley Rees's avatar
Hedley Rees
Feb 05, 2025
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INSIDE PHARMA
INSIDE PHARMA
What is Project Orbis and is it a Fast-track to Approving Cancer Drugs?
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Project Orbis

This is it taken from the FDA website:

FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma

“The U.S. Food and Drug Administration is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the Australian Therapeutic Goods Administration (TGA) and Health Canada collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in all three countries.”

Why just Oncology (cancer) Drugs?

You may be wondering why it is only Oncology drugs that are receiving such special treatment. As a critical thinker, you’d be right to consider that prospect. You may also be puzzled as to why only three regulatory ag…

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