OND Reorganization Continues Apace
Since Congress signed off on the reorganization of the US Food and Drug Administration’s Office of New Drugs (OND) in September, the process is now at nearly its midpoint and eight new offices are officially operating, FDA said in an update on Monday.The reorganization means the number of OND offices that oversee review divisions will increase from six to eight, and there will be increases in the number of OND clinical divisions from 19 to 27, plus six non-clinical review divisions.
FDA said Monday that the following offices are now up and running:
- Office of New Drug Policy
- Office of Drug Evaluation Sciences (ODES)
- Office of Program Operations,
- Immediate office of the Office of Regulatory Operations (ORO), and
- Immediate office of the Office of Administrative Operations.
- Office of Infectious Diseases
- Office of Oncologic Diseases
- Office of Neuroscience
The agency noted that the office director selection for ODES and the Office of Rare Diseases, Pediatrics, Urologic, & Reproductive Medicine is pending.
OND senior leadership determined that Phase III of the reorganization will begin on 13 January 2020 to accommodate “the high interest in leadership positions and scheduling interviews during the holiday season." Phase III includes the Office of Non-Prescription Drugs, the Office of Specialty Medicine and the Regulatory Operations Divisions associated with these therapeutic areas.
OND also said it’s still on track for the final phase (Phase IV) to begin in the February/March 2020 time frame.