FDA sorts formal sponsor meetings into four categories — Type A, B, C, and D — each with its own response timeline: A within 30 days, B within 60, C within 75, and D within 50. The category determines how long a sponsor has to prepare a briefing package and how broad the discussion can range, under FDA’s PDUFA VII meeting guidance.
Why FDA Categorizes Meetings at All
A sponsor developing a drug or biologic under FDA regulation will typically want to talk to the review division at several points: early in nonclinical development, before filing an Investigational New Drug (IND) application, at major efficacy milestones, and again before submitting a marketing application. Rather than handling every request the same way, FDA sorts meeting requests into categories based on urgency and scope, and commits to a response and scheduling timeline for each category under its PDUFA performance goals. Requesting the wrong meeting type — asking for a broad Type C discussion when the questions are actually narrow enough for a faster Type D, for example — can cost a sponsor weeks of avoidable delay.
Type A Meetings
Type A meetings are reserved for situations where a program is otherwise stalled and needs urgent resolution. Typical triggers include resolving a dispute between the sponsor and a review division, addressing an FDA-issued clinical hold, discussing a Special Protocol Assessment disagreement, or a post-action meeting after receipt of a Complete Response Letter. Because these meetings exist to unblock a program, FDA aims to hold a granted Type A meeting within 30 calendar days of receiving the request — the fastest turnaround of any category. Sponsors should not use Type A for routine milestone check-ins; FDA reserves the fast timeline for genuinely time-critical circumstances.
Type B Meetings (Including End-of-Phase)
Type B meetings are milestone meetings held at specific, predictable points in development. The most common examples are the pre-IND meeting, the End-of-Phase 2 (EOP2) meeting held after Phase 2 data are available and before a pivotal trial is designed, and the pre-NDA/BLA meeting held before a sponsor submits a New Drug Application or Biologics License Application. FDA’s guidance treats the End-of-Phase meeting as its own labeled sub-category, sometimes written as “Type B (EOP),” distinct from other Type B milestones, though it shares the same general timeline commitment. A sponsor is generally entitled to one Type B meeting per development phase per product, which is why sponsors are encouraged to consolidate every open nonclinical, CMC, and clinical-design question into a single, well-organized meeting request rather than raising them piecemeal across several smaller requests. FDA aims to hold a granted Type B meeting within 60 calendar days of receiving the request.
The FDA Pre-IND Meeting guide on this site walks through a full Type B meeting end to end — how it is requested, what the briefing package needs to contain, and the request-to-minutes timeline — using the pre-IND meeting specifically as the worked example.
Type C Meetings
Type C is the catch-all category for any meeting that does not fit the defined Type A or Type B milestones, but that still involves enough substance — more than two focused topics, or a complex single issue with several sub-questions — to warrant a broader discussion than a narrow Type D meeting would allow. Examples include a meeting to discuss a novel biomarker strategy, an unusual trial design not tied to a specific milestone, or a general development-program discussion outside the pre-IND/EOP2/pre-NDA sequence. FDA aims to hold a granted Type C meeting within 75 calendar days of receiving the request — the longest of the original three categories, reflecting both its lower urgency and its typically broader scope.
Type D Meetings
Type D is a newer, narrower meeting category, established as part of FDA’s PDUFA VII commitments (covering fiscal years 2023-2027) and detailed in FDA’s draft guidance on formal PDUFA meetings, issued September 2023 as an update to the prior December 2017 guidance. Type D meetings are limited to a genuinely narrow set of issues — typically no more than two focused topics, requiring input from no more than about three FDA disciplines. Examples include a discrete question about a complex or innovative trial design, or a follow-up clarification after a pre-BLA/NDA meeting where most substantive issues have already been resolved. Because the scope is deliberately constrained, FDA commits to a faster turnaround: a response or meeting within 50 calendar days of the request. Sponsors should not attempt to route a genuinely broad, multi-discipline discussion through a Type D request simply to get a faster date — FDA can and does redirect a request to the correct category if the scope doesn’t match.
INTERACT Meetings: A Related but Separate Category
INTERACT (Initial Targeted Engagement for Regulatory Advice) was introduced alongside Type D as part of the same PDUFA VII-driven guidance update. It is aimed at an earlier stage than any of the four lettered types: novel products and development programs facing issues that lack existing FDA guidance or established reference points, such as complex manufacturing questions, innovative device-drug combinations, or new methodological approaches. INTERACT meetings are optional and precede formal IND-enabling meetings like the pre-IND meeting; FDA aims to respond within 75 calendar days. Because INTERACT sits outside the formal Type A-D structure, it is worth treating as a distinct, earlier-stage option rather than a fifth lettered type.
Choosing the Right Meeting Type
- Program stalled or blocked (clinical hold, dispute, post-Complete-Response-Letter) → Type A
- Defined development milestone (pre-IND, End-of-Phase 2, pre-NDA/BLA) → Type B
- Substantive question outside the defined milestones → Type C
- One or two narrow, well-defined questions → Type D
- Very early-stage program with no existing FDA guidance to draw on → INTERACT
In every case, the request itself should state the proposed meeting type, the product and indication, a brief development history, and the specific questions to be addressed — FDA can reclassify a request if it disagrees with the sponsor’s proposed type, so a request that is honestly scoped from the outset moves faster than one that has to be renegotiated.
Frequently Asked Questions
What is the difference between a Type B and a Type B (EOP) meeting?
Both are milestone meetings under the same Type B category and share the same general timeline commitment. FDA’s guidance labels the End-of-Phase 2 meeting as its own named sub-category because of how central it is to pivotal-trial design, but procedurally it is requested and handled the same way as other Type B milestones such as the pre-IND meeting.
Can a sponsor request more than one Type B meeting per phase?
Generally, a sponsor is entitled to one Type B meeting per development phase per product. Sponsors who anticipate needing to raise several distinct issues at the same stage are encouraged to consolidate them into a single, well-organized request rather than submitting several separate ones, since FDA’s allocation is built around one meeting per milestone.
How does a sponsor know which meeting type to request?
The sponsor proposes a meeting type in its written request based on the scope and urgency of its questions, using the criteria above. FDA reviews the request and can redirect it to a different category (for example, downgrading an over-broad Type C request to a Type D, or vice versa) if it disagrees with the sponsor’s framing, which is one reason an honestly scoped request tends to move faster than one that overstates its urgency or narrowness.
Is a Type D meeting the same as a written-response-only meeting?
Not necessarily. Across meeting types, FDA may offer to respond to a sponsor’s questions in writing only, in lieu of holding a live meeting, when that is judged sufficient. Type D’s narrow scope makes it a common candidate for a written-response-only outcome, but the two are separate concepts: meeting type describes the subject-matter category, while written-response-only describes the format the interaction ultimately takes.
