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.
What You Need to Know? 👇
What is the difference between informal and formal meetings with OOPD?
Informal meetings address general questions about OOPD policies, designation processes, and basic terms through brief telephone conversations without requiring meeting packages. Formal meetings handle complex issues like orphan-drug exclusivity, denied designations, or complicated deficiency letters, requiring detailed meeting packages and more extensive preparation.
How long does OOPD take to respond to meeting requests?
OOPD aims to respond to meeting requests within 5 working days of receipt. They will determine the appropriate meeting type and work with stakeholders to identify convenient dates and times for all participants in a timely manner.
What should be included in a meeting package for formal OOPD meetings?
Meeting packages must include meeting details, purpose explanation, product information (name, designation number, rare disease), proposed agenda with detailed questions, supporting data/materials if needed, and a list of all expected participants with titles and affiliations.
When must meeting packages be submitted for formal OOPD meetings?
Meeting packages must be received by OOPD at least 2 weeks before the scheduled formal meeting. If packages are not received within this timeframe, OOPD may postpone the meeting due to inadequate preparation time and reschedule for a later date.
Who prepares meeting minutes after OOPD meetings?
Stakeholders are responsible for preparing draft meeting minutes within 15 working days following formal meetings and certain informal meetings. OOPD reviews and provides revisions within 15 working days, with the process continuing until both parties agree on final minutes.
What types of orphan product programs can be discussed in OOPD meetings?
OOPD meetings can address orphan-drug designations (including exclusivity), humanitarian use device (HUD) designations, rare pediatric disease designations, Orphan Products Grants Program, Pediatric Device Consortia Grants Program, and general patient-related orphan product topics.
What You Need to Do 👇
Recommended Actions
- Review OOPD website and FAQs before requesting a meeting
- Determine if informal or formal meeting is needed based on complexity of questions
- Submit meeting request via email with required minimum information
- For formal meetings, prepare and submit comprehensive meeting package 2 weeks in advance
- Follow meeting protocol including brief presentations and focusing on pre-submitted information
- Document meeting outcomes through meeting minutes within specified timeframes
- Maintain communication with OOPD contact for meeting coordination and follow-up
- Consider including relevant subject matter experts or patient representatives in meetings as needed
- Plan for adequate preparation time, especially for formal meetings
- 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
Related references and norms 📂
- 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 ID: aecbb6ad3142abb0a4eb47357ed6f25d