Overview
- Announced Nov. 11, Pazdur becomes director of the FDA’s Center for Drug Evaluation and Research, which oversees most prescription and over-the-counter medicines.
- Pazdur joined the FDA in 1999 and founded the Oncology Center of Excellence in 2017, where he will remain interim leader until a successor is chosen.
- He replaces George Tidmarsh, who left after federal ethics lawyers began reviewing concerns about his conduct, as a lawsuit from Aurinia alleged misuse of his position.
- CDER faces strained morale and staffing losses of more than 1,000 over the past year, as Commissioner Marty Makary advances faster-review efforts including a national priority voucher promising one- to two-month reviews.
- Known for expedited oncology pathways such as Project Orbis and for pulling back drugs that fail to show benefit, Pazdur is viewed by industry analysts as a stabilizing choice that could reduce regulatory uncertainty.