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The Office of Orphan Products Development (OOPD) is dedicated to promoting the development of products (drugs, devices, biologics, and medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. OOPD interacts with the medical and research communities, professional organizations, academia, the pharmaceutical industry, and rare disease patient groups. OOPD administers the major provisions of the Orphan Drug Act (ODA), which provide incentives for sponsors to develop products for rare diseases.
Each FDA-TRACK program area collects, analyzes, and reports its performance measures and results. Explore the progress OOPD is making towards its performance goals below.
Track workload and ensure timely review of orphan drug designation applications
Track workload and ensure timely review of HUD designation applications
Track workload and ensure timely review of RPD requests
Encourage clinical development of products for use in rare diseases or conditions
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time.