Each year, the Office of Orphan Products Development (OOPD) staff participates in meetings with stakeholders who seek guidance or clarification relating to orphan drug or HUD designation requests, OOPD grant programs, or other rare disease issues. These meetings can be “informal” or “formal” to help build a common understanding of FDA's thoughts on orphan products, which may include drugs, biological products, devices, or medical foods for a rare disease or condition.
Meetings with stakeholders may represent critical points in the orphan product development process, and may have an impact on the eventual availability of products for patients with rare diseases and conditions. It is important that these meetings be scheduled within a reasonable time, conducted effectively, and documented where appropriate. To effectively track and process designation meeting requests please email your request to:
The following draft guidance is intended to provide consistent procedures to promote well-managed meetings between OOPD and stakeholders.
For more information on your specific topic, please contact an OOPD staff member shown below. You may also contact OOPD through the main telephone number and email address:
For Drug Designations - General Questions
For Drug Designations - Oncology Related
For Rare Pediatric Disease Designations
For Humanitarian Use Device Designations
For Orphan Products Grants - Research Grants
For Pediatric Device Consortia Grants
Office of Orphan Products Development