US FDA Eyes Project Orbis-Type Approach For Cell And Gene Therapies
Executive Summary
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.
You may also be interested in...
The Risk-Reward Of US FDA Leadership Running Offices Below Them
CBER’s Celia Witten is the latest senior executive to run an office within the center during a leadership transition, a move that can help achieve specific goals, but also create tension.
FDA’s Cell, Gene Therapy Office Head Wilson Bryan Set To Retire
OTAT Director Bryan, who has worked at the FDA for more than 20 years, will depart by the end of March as the agency’s cell and gene therapy operations are poised for a major overhaul and a large number of new hires.
US FDA’s Real-Time Oncology Review Program Is No Guarantee For Early Approval
Early approvals may not be feasible for all submissions due to specific issues with an application or overall workload considerations, FDA says in a new draft guidance on the RTOR program; agency recommends bundling components of an RTOR application in a maximum of three partial submissions and a final submission.