Type D FDA Meeting: Request, Timeline, and User Fees

A Type D FDA meeting is a formal but narrowly scoped interaction between a drug or biologic sponsor and the FDA, created under the PDUFA VII reauthorization that took effect in fiscal year 2023. It is meant for one focused topic, or at most two, with a small number of associated questions that don’t require input from more than three FDA disciplines or divisions. The agency holds the meeting or issues a written response within 50 calendar days of receiving the request, and there is no separate user fee.¹

What a Type D Meeting Is For

The defining feature is tight scope. A Type D request should cover one topic, or no more than two, with a limited set of questions, and the answers should not require coordination among more than three FDA disciplines or divisions.²

The PDUFA VII commitment letter describes three situations that fit well: a follow-up question that raises a new issue after a prior formal meeting, a narrow standalone issue with only a few associated questions, or a general question about an innovative development approach that doesn’t need extensive detailed advice.¹ Examples from FDA’s Office of Tissues and Advanced Therapies include discussing a proposed efficacy endpoint for a clinical trial, clarifying a statistical analysis plan, or working through a potency assay question for chemistry, manufacturing, and controls.³

When to Choose a Different Meeting Type

A Type C meeting is the right vehicle if the request would involve more than two focused topics, if a single issue is complex enough to require many questions, if the questions would need input from more than three disciplines or divisions, or if the sponsor would otherwise need to file several Type D requests in close succession.² A Type B meeting fits when the topic calls for a comprehensive review of an entire development strategy.

Cross-center questions are also outside Type D scope. If an issue requires coordination between CDER and CBER, the agency will not handle it through a Type D interaction.

How to Request a Type D Meeting

The written request goes to the FDA through the electronic gateway, or for CDER submissions through the CDER NextGen Portal, addressed to the appropriate center and review division. Include the application number if one has been assigned, such as an IND, NDA, or BLA number.²

The meeting package is due at the same time as the request, not later.³ This is where avoidable delays happen. The package should contain:

Questions grouped by FDA discipline, clearly worded and targeted, with the total number appropriate for the narrow scope.
Enough background information and data for reviewers to answer without needing more.
The sponsor’s position on each question, with supporting rationale.
An attendee list identifying the technical personnel who will participate.

The Office of Tissues and Advanced Therapies caps Type D packages at five questions and two topics, with no more than three disciplines involved.³ Other divisions may set slightly different limits, but the two-topic and three-discipline ceiling from the agency-wide guidance applies across the board.² Vague or open-ended questions risk denial or reclassification.

Timeline From Submission to Response

Within 14 calendar days of receiving the request, the FDA notifies the sponsor whether the meeting is granted or denied.² If granted, the agency holds the meeting or issues a Written Response Only within 50 calendar days of receiving the request.³ That 50-day window is faster than the timelines for other meeting types, and the speed comes directly from the narrow scope.

Meeting Format and Preliminary Responses

Type D meetings are generally conducted virtually through video or audio conferencing, or handled entirely through a Written Response Only format with no live discussion.²

Before a scheduled meeting, the FDA sends the sponsor preliminary written responses to each question. In OTP’s practice, those arrive no later than five days before the meeting date.³ If the preliminary responses are clear and complete enough that further discussion isn’t needed, the sponsor can notify the FDA in writing to cancel the meeting, and those preliminary responses become the official record of the agency’s position.

If the sponsor proceeds with the live meeting, they must identify which of the original questions still need discussion and list them in proposed order, using the numbering from the FDA’s preliminary response. New questions or new data introduced after the preliminary response is issued are not allowed, and attempting to expand the discussion at that stage can lead to the meeting being canceled.³

Official Minutes

The FDA issues official minutes within 30 calendar days after the meeting.² These are not a transcript. They focus on clarifications of the preliminary responses, agreements and disagreements between the sponsor and the agency, and any action items from the discussion.³ The FDA’s version is the official and final record.

If a sponsor sees a significant difference between what was discussed and what the minutes reflect, the first step is contacting the FDA project manager. If that doesn’t resolve it, the sponsor submits a written description of the specific disagreements to the division director, copying the project manager. If the FDA concludes the minutes are accurate, they stand. If the agency agrees a change is warranted, it issues an addendum documenting the correction and any remaining sponsor objections.²

Reclassification and Denials

An overscoped Type D request is not simply rejected. If the request is too broad, involves complex questions requiring more than three disciplines, needs cross-center responses, or requires additional regulatory review, the FDA will notify the sponsor that the meeting is being converted to a Type B or Type C meeting. The sponsor can then accept the conversion without resubmitting or withdraw the request entirely.² Accepting the conversion means longer timelines under the receiving meeting type’s scheduling window, but it avoids drafting a new package.

The FDA may also deny a request outright if the meeting is premature for the current stage of development, if the package doesn’t support a meaningful discussion, or if required elements are missing. Even after a request is granted, the agency can cancel the meeting if the submitted package is grossly inadequate, or if the sponsor sends additional questions or data that would require extra review time.²

User Fees

Type D meetings do not carry a separate user fee. The FDA’s fiscal year 2026 PDUFA fee schedule sets fees only for drug applications and prescription drug program fees, not for individual meeting requests.⁴ The cost of conducting these meetings is built into the broader PDUFA fee structure, so sponsors already paying program fees are not billed separately for requesting a Type D interaction.

1
Food and Drug Administration. PDUFA Reauthorization Performance Goals and Procedures
2
Food and Drug Administration. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
3
U.S. Food and Drug Administration. OTP Type D Meetings
4
Federal Register. Prescription Drug User Fee Rates for Fiscal Year 2026