CDER Quality Office Reorganizing Next Year

CDER director Patrizia Cavazzoni says the Office of Pharmaceutical Quality will reorganize effective 1/14/2024. She says the reorganization “streamlines the office’s core functions to bring added flexibility without compromising accountability.”

Under the change, the Office of New Drug Products, Office of Lifecycle Drug Products, and Office of Biotechnology Products will become three Offices of Pharmaceutical Quality Assessment.

According to Cavazzoni, other changes will include:

• centralizing all research under a new Office of Pharmaceutical Quality Research;
• consolidating all quality assessment activities, including project management of application assessments, under the deputy director of science; and
• establishing an Office of Quality Assurance that will include enterprise project management not related to drug applications, quality management system, enterprise risk management, and training and development activities.