U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. Transparency
  4. FDA-TRACK: Agency-wide Program Performance
  5. FDA-TRACK: OCPP OOPD Dashboard
  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: OCPP OOPD Dashboard

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 OCP is making towards it's performance goals below.


Orphan Drug Designation Application Review Time Measures

Track workload and ensure timely review of orphan drug designation applications

Return to top


Humanitarian Use Device (HUD) Designation Application Review Time Measures

Track workload and ensure timely review of HUD designation applications

Return to top


Rare Pediatric Disease (RPD) Priority Review Voucher (PRV) Program Measures

Track workload and ensure timely review of RPD requests

Return to top


Orphan Products (Clinical Trials) Grants Program Measures

Encourage clinical development of products for use in rare diseases or conditions

Return to top


 

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.

 

Sign up to receive FDA-TRACK updates

Get regular FDA email updates delivered on this topic to your inbox.

Back to Top