FDA’s Office of Generic Drugs Receives Approval to Undergo Reorganization

Statement from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced the approval of the Office of Generic Drugs’ (OGD) reorganization. The new structure, which will become effective at a later date in 2021, will strengthen OGD’s operations and allow the office to meet the evolving needs of generic drug review while upholding FDA’s international reputation as the gold standard in the assessment and monitoring of generic drugs.

The guiding principles of the reorganization are to improve efficiency and consistency across OGD, and enhance collaboration and operational effectiveness. The reorganization will more effectively resource and support the high volume of generic drug applications FDA receives every year and will support the essential and intricate work of the generic drug program.

hanges include establishing a new Office of Safety and Clinical Evaluation. The new office will consist of the Division of Clinical Review and the Division of Pharmacology Toxicology Review, both being realigned from OGD’s Office of Bioequivalence; and the Division of Clinical Safety and Surveillance, being realigned from OGD’s Immediate Office.

New divisions will be established in existing OGD Offices, including the Division of Bioequivalence Process Management (Office of Bioequivalence), the Division of Therapeutic Performance II (Office of Research and Standards), and the Division of Orange Book Publication and Regulatory Assessment (Office of Generic Drug Policy). Lastly, the Division of Quality Management Systems will move from the Office of Regulatory Operations to become the Quality Management Systems Staff within OGD’s Immediate Office.

Through the reorganization, OGD intends to continue its focus on ensuring a more efficient review process and create a stronger alignment of administrative, regulatory project management, program operations, policy, and drug development tool services. Modernizing OGD operations will help staff perform FDA’s mission effectively in an environment of rapidly evolving science, changing stakeholder expectations, and new statutory authorities and responsibilities.

The reorganization, along with new processes and policies, bolsters CDER’s mission to ensure that safe, effective, high-quality generic drugs are available for the American public.