By Greg Slabodkin, ScienceBoard Editor in Chief
The U.S. Food and Drug Administration (FDA) has elevated and reorganized its Office of Tissues and Advanced Therapies (OTAT) to a “Super Office” within the Center of Biologics Research and Evaluation (CBER) to meet its growing cell and gene therapy workload.
“With the current and anticipated increase in workloads, the proposed structural changes will improve functional alignment, increase review capabilities, and enhance expertise on new cell and gene therapies,” the FDA announced last week in the Federal Register.
CBER’s OTAT has been renamed the Office of Therapeutic Products (OTP) and is part of the FDA’s commitments negotiated with industry under the Prescription Drug User Fee Act (PDUFA) VII agreement for fiscal years 2023-2027.
A report published last week by the Alliance for Regenerative Medicine (ARM) on the state of the cell and gene therapy industry noted that the upcoming reauthorization of PDUFA by the U.S. Congress “will provide vital funding for new personnel and programs to support FDA review of the coming wave of new therapies.”