Type A/B/C Meeting
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
Type A, B, and C meetings are FDA’s formal, scheduled meeting categories with drug and biologic sponsors, distinguished by purpose and response timeline: Type A meetings resolve stalled development programs and are scheduled within 30 days; Type B meetings cover milestone discussions such as pre-IND or pre-NDA/BLA meetings, scheduled within 60 days; Type C meetings cover other product-development topics, scheduled within 75 days.
Each meeting type follows a defined process: the sponsor submits a written meeting request describing the purpose and proposed questions, FDA responds with a scheduled date, or, for some meeting types, a written-response-only alternative in lieu of a live meeting, and the sponsor submits a background package by an agreed deadline before the meeting occurs.
Additional subtypes have been added over time for specific programs — for example, INTERACT meetings for very early-stage development questions, and expedited-program meetings tied to Breakthrough Therapy or Fast Track status — but the core Type A/B/C framework and its response-time commitments remain the backbone of formal sponsor-FDA interaction throughout a development program.
- —Type A: resolves a stalled program, scheduled within 30 days
- —Type B: milestone meetings (e.g., pre-IND, pre-NDA/BLA), scheduled within 60 days
- —Type C: other development topics, scheduled within 75 days
- —Requires a written meeting request and a background package ahead of the meeting
- —Timelines are FDA performance commitments made under PDUFA, not statutory deadlines
21 CFR 312.47 (meetings, IND regulations); FDA guidance “Formal Meetings Between FDA and Sponsors or Applicants”; PDUFA reauthorization commitment letters
Frequently asked questions
What is Type A/B/C Meeting?
Type A, B, and C meetings are FDA’s formal, scheduled meeting categories with drug and biologic sponsors, distinguished by purpose and response timeline: Type A meetings resolve stalled development programs and are scheduled within 30 days; Type B meetings cover milestone discussions such as pre-IND or pre-NDA/BLA meetings, scheduled within 60 days; Type C meetings cover other product-development topics, scheduled within 75 days.
Which regulations cover Type A/B/C Meeting?
21 CFR 312.47 (meetings, IND regulations); FDA guidance “Formal Meetings Between FDA and Sponsors or Applicants”; PDUFA reauthorization commitment letters