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  • Feature ArticlesFeature Articles

    Project Orbis: Maximizing patient access to new medicines

    To ensure equitable access to new medicines for all patients, drug manufacturers aim to register new products in as many countries as possible. Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), is a pilot program that provides applicants with a framework for concurrent submission and review of oncology products among international partners to allow earlier registration in countries outside of the US. This article summarizes Genentech’s experience...