FDA Officials Announce New Pathway for Bespoke Gene Therapies

Scientists created a customized gene editing therapy for a baby, which corrected the genetic variants, researchers said.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023.Madalina Vasiliu/The Epoch Times

Top Food and Drug Administration officials on Nov. 12 said there’s a new pathway for custom gene editing therapies for people with serious diseases.

The FDA will consider clearing bespoke therapies if a manufacturer shows success with several patients, Dr. Marty Makary, the FDA’s commissioner, and Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, said in an article published by the New England Journal of Medicine.