Reorganization of FDA's Office of Generic Drugs approved

On Friday, the US Food and Drug Administration’s 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 the 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 the 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.