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".
Dr Stephanie Krumholz
General Manager, Switzerland