What is Project Orbis and who is qualified for filing through this new pathway? In this article, published in the December issue of Pharmafocus, Dr Stephanie Krumholz, NDA's Project Orbis expert, answers these questions and explains why this is such an exciting initiative from the FDA.

Project Orbis is a framework for submission and review of oncology products that was launched by the FDA Oncology Center of Excellence in 2019. It represents the next level of international regulatory co-operation and transparency with parallel filings in several different jurisdictions and a concurrent, yet independent evaluation.

"Project Orbis", Dr Krumholz says, "is a fantastic opportunity for enhanced collaboration between regulatory agencies across the world and for bringing oncology medication to patients with a high medical need".


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The Author

Dr Stephanie Krumholz

General Manager, Switzerland


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