Sarah Barkow is a Team Lead for Manufacturing Quality Guidance and Policy in CDER’s Office of Manufacturing Quality at the FDA. She was co-lead author on the recently released draft guidance for industry, Data Integrity and Compliance With CGMPs. Dr. Barkow holds her Ph.D. in Physical Chemistry from MIT, where she worked on molecular motors. Prior to joining the FDA, she worked as a team lead for immunoassay development at Beckman Coulter.