Definition
FDA Meeting Types categorize sponsor-FDA consultations by priority and purpose. Type A meetings address urgent issues, Type B covers major development milestones, and Type C handles other development questions. Each type has specific scheduling timelines.
Meeting Types Comparison
| Type | Priority | Scheduling | Purpose |
|---|---|---|---|
| Type A | Highest | 30 days | Stalled programs, disputes, safety issues |
| Type B | High | 60 days | Pre-IND, EOP2, Pre-NDA/BLA milestones |
| Type C | Standard | 75 days | Other development questions |
| Type D | Administrative | N/A | Administrative or procedural matters |
Type B Meeting Categories
Type B meetings include specific milestone consultations:
- Pre-IND: Before submitting IND application
- End of Phase 1: After initial human trials
- End of Phase 2: Critical for Phase 3 design
- Pre-NDA/Pre-BLA: Before submitting marketing application
- Post-Action: After FDA decision on application
Why BD Teams Track FDA Meetings
For business development professionals, FDA meeting history indicates regulatory engagement:
- Deal Implication: Documented FDA alignment through Type B meetings reduces development risk
- Due Diligence Focus: Request meeting minutes to assess regulatory relationship and guidance received
- Opportunity Signal: Active FDA dialogue suggests sophisticated regulatory strategy