Eye on FDA

Dr. George Tidmarsh has been selected to replace Dr. Jacqueline Corrigan-Curay as the director of the Center for Drug Evaluation and Research (CDER) at FDA as she prepares to retire from the agency. Dr. Tidmarsh is an adjunct professor of pediatrics and neonatology at Stanford University and is credited as having been involved in the development of several approved drugs. Until late May of this year, Dr. Tidmarsh was a member of the board of directors of Revelation Biosciences, a company engaged in developing an anti-inflammatory IV therapy. Among other roles and experiences he has had, he was a founding Co-Director of Stanford’s Master of Science in Translational Research and Applied Medicine (M-TRAM) program, and founded Horizon Pharma in 2005.

On October 9, the FDA announced that the agency is providing exemptions from the enhanced drug distribution security requirements of section 582 of the Federal Food, Drug and Cosmetic Act (FD&C Act) for eligible trading partners, which were scheduled to take effect on November 27. This exemption applies to drug products transacted by trading partners that have successfully completed (or made documented efforts to complete) data connections with their immediate trading partners, but still face challenges exchanging data.