Steven Oh Ph.D.

Dr. Steven Oh provides leadership in reaching regulatory decisions on advanced therapy regenerative medicine products such as cellular and gene therapy products, tissue-engineered products, combination products, and point-of-care devices submitted to CBER, FDA. Dr. Oh is actively engaged in developing CBER policies addressing regulatory challenges that involve cross-cutting science and emerging technologies in regenerative medicine therapy. He also participates in efforts to develop international standards for manufacturing and testing cellular, tissue-engineered, and gene therapy products as well as in various activities promoting global regulatory convergence for these products. Before joining FDA in 2007, Dr. Oh served on the faculty of Tufts University School of Medicine in Boston. He was trained as a cell biologist and biochemist at Massachusetts Institute of Technology, Johns Hopkins University School of Medicine, and the University of Michigan.