White Papers related to Innovations to Market

Project Orbis is an international collaborative e-framework initiated by the United States (US) Food & Drug administration (FDA) Oncology Center of Excellence (OCE) in May 2019. It was created to achieve one main objective, which is to facilitate the submission, review, and approval of oncology medicinal products. This framework allows concurrent submission and review amongst the Project Orbis Partners (POPs).

Globalization has broadened opportunities for companies to make their products available to more people in more markets, while at the same time ensuring patients in emerging markets have access to products that can change or even save lives.