U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. About FDA
  3. FDA Organization
  4. Center for Drug Evaluation and Research (CDER)
  5. Office of New Drugs (OND) | Annual Reports
  1. Center for Drug Evaluation and Research (CDER)

Office of New Drugs (OND) | Annual Reports

The 2023 OND Annual report captures the office's achievements, including notable drug approvals, guidances, publications, and staff's involvement in public meetings, workshops, webinars, and conferences. This report showcases OND's contribution to innovative approaches in drug development, including use of novel trial design and endpoints that can facilitate the approval of safe and effective therapies, especially in areas of unmet need. It also highlights the office's collaborations throughout FDA and with external parties to address new challenges in drug development and regulation.

Back to Top