Office of New Drugs Reorganization Enters New Phase

The third phase of restructuring at the Office of New Drugs is underway, setting up an Office of Nonprescription Drugs and an Office of Specialty Medicine.

The reorganization may affect some applications currently under review, and sponsors will be notified if there is a change in point-of-contact for their submissions, OND Director Peter Stein said in an email to drug sponsors. The new phase will be implemented “over the next several weeks,” he said.

The Office of Nonprescription Drugs — formerly the Division of Nonprescription Drug Products — will be led by Terri Michele in an acting role. The Office of Specialty Medicine will be led by Charles Ganley.

The Office of Specialty Medicine will include the Division of Ophthalmology and the Division of Medical Imaging and Products, which will be renamed the Division of Medical Imaging and Radiation Medicine.

Eight new offices established under the first two phases of reorganization are officially up and running. The final phase of the OND reorganization is expected to begin in February or March.