US FDA to develop new guidance, anticipates surge in cell and gene therapies

US Food and Drug Administration Commissioner Scott Gottlieb has issued a statement regarding the new policies the agency is implementing to advance the development of cell and gene therapies.

Dr Gottlieb said the agency is “witnessing a surge of cell and gene therapy products entering early development,” and that “we anticipate that the number of product approvals for cell and gene therapies will grow in the coming years.”

The FDA says that by 2020 it will be receiving more than 200 Investigatinal New Drug (IND) applications per year, adding to the more than 800 active cell-based or directly administered gene therapy INDs currently on file. By 2025, the agency predicts it will be approving up to 20 cell and gene therapy products a year.