FDA to Create a New Office to Evaluate Cutting-Edge Science

The U.S. Food and Drug Administration (FDA) plans to create a new department called the Office of Drug Evaluation Science (ODES) that will standardize the review of new medicines. FDA Commissioner Scott Gottlieb, MD, spoke with STAT News about his vision for the 52-person group, saying he imagines “a world where data will be uploaded from drug company studies into the cloud, and instead of looking at the charts and tables companies create themselves, the FDA will use its own standardized methods on the raw data.”

Targeted immunotherapies often rely on testing that is inconsistent across companies. For example, the cancer medications pembrolizumab, nivolumab, and durvalumab (all PD1 inhibitors) use different measures to test for the presence of PDL1.

Dr. Gottlieb expects ODES to begin operating in 2019.

Source: STAT News, January 7, 2019.