The OTP was established in March 2023 to deal with the ever-increasing pace of cell and gene therapies. It is the first super office at CBER, with six sub-offices, 14 divisions and 33 branches.
The initiatives coincide with an increase in the volume of data submitted to CDER and CBER—particularly in cell and gene therapy.
Operation Warp Speed worked so well to accelerate the development of COVID-19 vaccines the FDA now has its sights set on a similar initiative for rare disease treatments.
“The FDA views gene therapy as an excellent opportunity to expedite the delivery of potentially life-saving therapies to patients with rare diseases,” said Marks, who heads the FDA’s Center for Biologics Evaluation and Research, in a statement.