Posted by Michael Wonder on 02 Nov 2023
FDA notes “continued growth” of Orbis collaborative review program, adds EMA as observer
1 November 2023 - There has been “continued growth” in the number of applications submitted to Project Orbis, and the EMA has announced plans to join the multi-country review consortium as an observer, R. Angelo de Claro, the division director for FDA’s Office of Oncologic Diseases at the Center for Drug Evaluation and Research.
De Claro offered an update on Project Orbis during the Pharmaceutical Quality Symposium sponsored by the Small Business and Industry Assistance program at the FDA Center for Drug Evaluation and Research on 1 November 2023.
