The FDA conducts formal regulatory meetings with drug and biologics sponsors under the Prescription Drug User Fee Act (PDUFA VII) framework. Interactions are categorized by purpose, urgency, and development stage.
FDA Formal Meeting Types
| Meeting Type | Purpose & Scope | Key Examples | Response Timeline | Scheduling / Decision Window |
| INTERACT | Early Targeted Advice: For novel products/platforms before Pre-IND. | Gene therapies, innovative drug-device combinations, novel delivery systems. | 21 Days | 75 Days (Package due at submission) |
| Type A | Urgent / Stalled Programs: Critical path resolution or safety issues. | Clinical hold discussions, Special Protocol Assessment (SPA) disputes. | 14 Days | 30 Days (Package due within 3 weeks) |
| Type B (Milestone) | Core Development Milestones: Key inflection points in product lifecycle. | • Pre-IND • Pre-NDA / Pre-BLA • REMS or Post-marketing | 21 Days | 60 Days (Package due 30 days prior) |
| Type B (EOP) | End-of-Phase Milestones: Pivotal trial design & safety evaluation. | • End-of-Phase 1 (EOP1) • End-of-Phase 2 (EOP2) / Pre-Phase 3 | 21 Days | 70 Days (Package due 50 days prior) |
| Type C | General Development: Any topic not covered by Type A, B, or D. | Biomarker usage, chemistry, manufacturing, and controls (CMC) updates, protocol advice. | 21 Days | 75 Days (Package due 47 days prior) |
| Type D | Narrow Focus: Rapid feedback on specific, targeted questions. | Max 5 questions total, max 2 FDA disciplines involved (e.g., CMC only or Clinical only). | 14 Days | 50 Days (Package combined with request) |
What You Need to Know
1. Available Meeting Formats
When submitting a request, you specify a preferred format:
In-Person / Hybrid: Core team attends at FDA headquarters; secondary attendees join virtually.
Virtual Face-to-Face (VCN): Live video conference.
Teleconference (TCN): Audio-only call.
Written Response Only (WRO): FDA provides written feedback without a live conversation. (FDA frequently converts Type C and Pre-IND requests to WRO).
2. Preparing the Meeting Package
The Briefing Document (Meeting Package) dictates the success of your FDA interaction:
Clear, Actionable Questions: Avoid open-ended queries like “Does the FDA agree with our plan?” Instead, state your position: “Sponsor proposes X methodology based on Y data. Does the FDA concur?”
Page & Question Limits: Limit questions to 10 or fewer per meeting (Type D is strictly limited to 5). Keep briefing materials concise and focused.
Combined Submissions: For INTERACT and Type D meetings, your meeting package must be submitted simultaneously with the meeting request.
3. Execution & Post-Meeting Steps
Preliminary Responses: The FDA usually provides draft written responses 24–48 hours prior to a live meeting. Use these draft answers to cancel unnecessary questions and focus the live meeting exclusively on areas of disagreement.
Meeting Minutes: The FDA issues official meeting minutes within 30 days of the meeting.
Clarifying Questions: If minutes contain ambiguous statements, sponsors have 20 calendar days to submit clarifying questions (no new questions permitted).
