A process in which the FDA coordinates reviews with other regulators would allow for better leveraging of global patient populations with ultra-rare diseases and attract more commercial interest in a given disease area, CBER’s Peter Marks tells the Biopharma Congress. The biologics center also looks to apply the philosophy underlying the Real-Time Oncology Review program.
The US Food and Drug Administration is eyeing potential adoption of a Project Orbis-type approach for cell and gene therapies to treat rare diseases.
A process where the FDA can coordinate reviews with other regulators would allow for better leveraging of global patient populations...