FDA boosts Office of Generic Drugs in reorganization
- There have been several key managerial changes at the Office of Generic Drugs (OGD). Kathleen “Cook” Uhl, MD, will retain her position as acting director of OGD.
- OGD will become an office that reports directly to the director of FDA’s Center for Drug Evaluation and Research (CDER). This is a step up.
- This reorganization is part of a larger effort to expedite approval of high-quality generic drugs, while ensuring that they are safe and efficacious.
Considering that 84% of all prescriptions filled are for generic drugs, there is need for a regulatory review process that is transparent and efficient. To help achieve this, there have been several managerial reassignments at OGD, including assigning Ron Lionberger to lead the Office of Research and Standards and Jason Woo to lead the Office of Regulatory Operations. In addition, John Peters will lead the Office of Bioequivalence and Keith Flanagan will lead the Office of Generic Drug Policy.
- First Word Pharma Office of Generic Drugs Reorganization