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). Already, Project Orbis has resulted in a number of approvals and many more oncology products are going through application reviews with the various member countries.
This white paper will summarize how sponsors can get their oncology product approved via Project Orbis and how sponsors can use services provided by PharmaLex and take advantage of our experience with the Project Orbis pathway.