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Meetings with the Office of Orphan Products Development: Procedures and Best Practices

This guidance provides recommendations for stakeholders requesting meetings with FDA's Office of Orphan Products Development (OOPD) regarding orphan drug designations, humanitarian use device designations, rare pediatric disease designations, funding opportunities, and orphan product patient-related topics. It outlines procedures for requesting, preparing, scheduling, conducting, and documenting both informal and formal meetings.

  1. Review OOPD website and FAQs before requesting a meeting
  2. Determine if informal or formal meeting is needed based on complexity of questions
  3. Submit meeting request via email with required minimum information
  4. For formal meetings, prepare and submit comprehensive meeting package 2 weeks in advance
  5. Follow meeting protocol including brief presentations and focusing on pre-submitted information
  6. Document meeting outcomes through meeting minutes within specified timeframes
  7. Maintain communication with OOPD contact for meeting coordination and follow-up
  8. Consider including relevant subject matter experts or patient representatives in meetings as needed
  9. Plan for adequate preparation time, especially for formal meetings
  10. Follow up on any action items identified during the meeting

Key Considerations

Other considerations

  • Two types of meetings are defined: informal and formal meetings
  • Informal meetings are for general questions about policies, procedures, and basic designation terms
  • Formal meetings address specific and complex questions related to designation requests, denials, and exclusivity
  • Meeting requests should include purpose statement, meeting type preference, suggested dates/times, format preference
  • For formal meetings, a meeting package must be submitted 2 weeks before the meeting
  • Meeting package must include date/time, purpose, product information, agenda, supporting data, and participant list
  • Meeting minutes required for all formal meetings and certain informal meetings
  • Stakeholders must provide draft minutes within 15 working days after the meeting

    Relevant Guidances

  • Humanitarian Device Exemption (HDE) Program: Operational Requirements and Benefit-Risk Assessment
  • Humanitarian Use Device (HUD) Designation Requests: Content and Format
  • 21 CFR Part 316: Orphan Drugs
  • 21 CFR Part 814, Subpart H: Humanitarian Use Devices

Original guidance

  • Meetings with the Office of Orphan Products Development: Procedures and Best Practices
  • HTML / PDF
  • Issue date: 2015-07-09
  • Last changed date: 2024-04-11
  • Status: FINAL
  • Official FDA topics: Medical Devices, Pediatric Product Development, Drugs, Biologics, Administrative / Procedural
  • ReguVirta summary file ID: aecbb6ad3142abb0a4eb47357ed6f25d
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