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U.S. Department of Health and Human Services

For Industry

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Meeting with OOPD

Each year, the Office of Orphan Products Development (OOPD) participates in meetings with stakeholders who seek guidance or clarification relating to orphan drug or humanitarian use device (HUD) designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants program, or other rare disease issues. These meetings can be “informal” or “formal” and help build a common understanding on FDA’s thoughts on orphan products, which include drugs, biological products, devices or medical foods. These meetings may represent critical points in the orphan product development process and may even have an impact on the eventual availability of products for patients with rare diseases and conditions. It is important to OOPD that these meetings be scheduled within a reasonable time frame, conducted effectively, and documented where appropriate. As such, OOPD is announcing the availability of a draft guidance to assist stakeholders with requesting, preparing, scheduling, conducting, and documenting meetings with OOPD. This draft guidance generally documents OOPD’s existing practices regarding meetings with stakeholders and provides a process that stakeholders can follow.
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
(301) 796-8660