Restructuring of CDER’s Office of New Drugs Passes Half-Way Mark

The restructuring of CDER’s Office of New Drugs, which began in September, has hit the midway point and is about to enter a new phase.

The agency has now chosen most of the directors for its eight new offices: the Office of New Drug Policy; the Office of Drug Evaluation Sciences; the Office of Program Operations; the Office of Infectious Diseases; the Office of Oncologic Diseases; the Office of Neuroscience; the Immediate office of the Office of Regulatory Operations; and the Immediate office of the Office of Administrative Operations. The names of the office heads have not yet been made public.

The reorganization’s third phase is set to begin on Jan. 13, 2020. It will put in place the Office of Non-Prescription Drugs and the Office of Specialty Medicine. Two accompanying divisions will also be set up to handle regulatory operations for the new offices.

The final phase of reorganization is set to begin in February or March 2020, and will form the Office of Cardiology, Hematology, Endocrinology and Nephrology, the Office of Immunology and Inflammation, and the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine.