Overworked and ready for expansion: FDA's cell and gene therapy office preps to add about 100 new positions
Housed within the FDA’s Center for Biologics Evaluation and Research, the once-tiny Office of Tissues and Advanced Therapies, which regulates all cell and gene therapy products, has been pummeled with a workload that now includes more than 3,000 active INDs.
That punishing workload has translated into OTAT staff defections, the office director, Wilson Bryan, told participants Monday at the American Society of Gene and Cell Therapy’s policy summit.
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