FDA Braces for Looming Boom in Cell and Gene Therapy Submissions

The FDA is preparing for a surge in cell and gene therapy submissions, with up to 10 regulatory decisions expected this year alone. The establishment of the Office of Therapeutic Products (OTP) is part of the FDA's response to the growing demand for regulatory review of these therapies. However, experts have warned that modernization of both the regulatory and access and reimbursement frameworks..