TL;DR
- FDA sorts formal meetings with drug and biologic sponsors into three types — A, B, and C — based on urgency and purpose, under the framework FDA published in its formal meetings guidance for industry (FDA: Formal Meetings Between the FDA and Sponsors or Applicants Guidance).
- A Type A meeting is for stalled programs or disputes and gets FDA's fastest response — generally scheduled within 30 days of the request.
- A Type B meeting covers standard development milestones, like pre-IND, end-of-Phase 2, or pre-NDA/BLA meetings, generally scheduled within 60 days.
- A Type C meeting is for any other topic a sponsor wants to discuss with FDA that doesn't fit Type A or B, generally scheduled within 75 days.
What Are FDA Type A, B, and C Meetings?
If you've heard a regulatory affairs team say "we're requesting a Type B" and wondered what that actually means, it's shorthand for a formal, scheduled meeting with FDA, one of three standardized categories the agency uses to triage meeting requests by urgency and topic under its user-fee-linked formal meetings guidance (FDA: Formal Meetings Guidance).
Type A Meetings: Fastest, Reserved for Stalled or Disputed Programs
Type A meetings are for situations where a development program is stuck or in dispute — a clinical hold, a special protocol assessment disagreement, or a dispute resolution request, for example. Because these situations can stop a program cold, FDA commits to scheduling Type A meetings the fastest among the three categories, generally within 30 days of receiving the request.
Type B Meetings: Standard Development Milestones
Type B meetings cover the milestone conversations most sponsors are familiar with: pre-IND meetings before starting human trials, end-of-Phase 1 meetings for certain products, end-of-Phase 2 meetings before starting pivotal trials, and pre-NDA or pre-BLA meetings before submitting a marketing application. These are generally scheduled within 60 days of the request. Each product is generally entitled to one of certain Type B meeting types per phase of development under the guidance.
Type C Meetings: Everything Else
A Type C meeting is the catch-all category — any meeting that doesn't fit the Type A or B definitions but that a sponsor wants with FDA on a topic related to development of the product. This might include early discussions about a novel endpoint, a biomarker strategy, or a general development question outside the standard milestone sequence. Type C meetings are generally scheduled within 75 days of the request.
Type A, B, and C Meetings, Side by Side
| Type A | Type B | Type C | |
|---|---|---|---|
| Purpose | Stalled or disputed programs | Standard development milestones | Any other development topic |
| Example | Clinical hold response, dispute resolution | Pre-IND, end-of-Phase 2, pre-NDA/BLA | Biomarker or novel endpoint discussion |
| Target scheduling window | ~30 days | ~60 days | ~75 days |
| How often per product | As needed for the triggering event | Generally limited per development phase | As needed, subject to FDA agreement |
FAQ
Do these meeting types apply to medical devices too?
The Type A/B/C framework as described here is specific to drug and biologic products under the prescription drug and biosimilar user fee programs. Devices have a related but separately structured set of interactions with FDA, including pre-submission meetings, governed by their own guidance documents.
Can FDA deny a meeting request?
FDA can decide a formal face-to-face meeting isn't necessary and instead offer to respond in writing or by teleconference, depending on the topic and the specificity of the sponsor's briefing materials.
What has to happen before a meeting is granted?
Sponsors typically submit a meeting request along with a proposed agenda and, for most meeting types, a briefing document with specific questions for FDA, submitted a set number of days before the scheduled meeting date so FDA's review team can prepare.
Does a Type A meeting guarantee FDA will resolve the dispute in the sponsor's favor?
No. The Type A designation only affects how quickly FDA commits to meeting, not the outcome — FDA can still maintain its original position, including on a clinical hold or dispute resolution request, after the meeting occurs.
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Sources: FDA: Formal Meetings Between the FDA and Sponsors or Applicants Guidance, 21 CFR Part 312 (eCFR). Byline: The Argus Regulatory Analysis Team. Published 2026-07-16.