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How do you prepare a useful FDA PDUFA meeting request?
Identify the development decision, applicable meeting program and proposed type before choosing a date. Provide focused questions with their context, the requested format, agenda, attendees and package date. Match the scope and evidence readiness to the meeting type, then reconcile the plan with FDA’s granted-meeting instructions. The August 2026 final guidance governs this guide’s PDUFA framework.
Before you begin
Formal meetings for PDUFA products under the August 2026 final guidance. BsUFA, GDUFA, device and other programs have different meeting rules.
What you will prepare: A decision-focused meeting request and confirmed package timetable.
Sections covered in this guide (2)
Choose the program and meeting purpose before the date
The meeting family contains the request, background package and later correspondence. First identify the responsible center/division, application or pre-application record, development stage, unresolved decision and the program governing the meeting. Do not apply PDUFA meeting labels or deadlines to an ANDA or biosimilar meeting without checking its separate framework.
Under the final guidance, Type A, Type B, Type B (end-of-phase), Type C, Type D and INTERACT have distinct roles. Type D is for a narrow set of issues, generally one or at most two focused topics, not a large development-program review split into many small requests. Justify the proposed type from the decision needed, and recognize that FDA determines the final type and format.
Write questions that expose the proposed decision
Include product/application identity, proposed indication and development context, meeting type and rationale, requested format, purpose, agenda with discussion times, focused questions, proposed dates, planned attendees and requested FDA disciplines. State when the package will be supplied. The guidance generally recommends no more than ten total questions including subquestions; a shorter list does not excuse missing evidence.
For each question, provide the sponsor’s position and a short justification. Fictional example: “Does FDA agree that the proposed primary endpoint and assessment window in protocol draft [version] are suitable for the intended efficacy claim, given [identified evidence and limitation]?” This is more actionable than “Is our program acceptable?” Do not insert invented supporting results into the bracketed evidence.
Plan format and package together
The final guidance distinguishes hybrid in-person face-to-face, virtual face-to-face, teleconference and written response only. A request for a format is not confirmation of that format. Assemble attendees who can answer the specific questions and justify unusual requested FDA participation.
Package timing depends on type: Type A, Type D and INTERACT packages accompany the request; a Type C consultation on a new surrogate endpoint used as the primary approval basis also has that requirement. Other Type C, Type B and end-of-phase packages follow the specific timing table and its exceptions. Record the current guidance deadline and FDA’s actual granted-meeting instructions together before committing the authoring schedule.
Worked check: a Type D request contains a whole development plan
Fictional exercise: a proposed Type D request includes efficacy design, formulation comparability, toxicology and pediatric strategy with many subquestions. The issue count and disciplines do not fit a narrow request. Reassess the meeting type and prioritize a coherent decision set rather than deleting headings while retaining all questions.
If the application pathway is unknown, continue assembling evidence but leave meeting classification undetermined. If the key results will not be ready for the package, reassess whether the meeting can be productive.
Turn the question list into a decision and package plan
Give every question one number and one clear purpose. The final guidance recommends counting subquestions separately, with no more than ten total questions. Writing four headings with three decisions under each does not create a four-question request.
| Question-planning field | What a useful entry establishes |
|---|---|
| Development decision | The choice the team will make after receiving advice |
| Proposed approach | The specific design, analysis or manufacturing approach to be discussed |
| Evidence and limitation | Why the proposal is reasonable and what remains uncertain |
| FDA expertise | Disciplines needed to answer the actual question |
| Discussion priority | Why the question needs meeting time and how it fits the agenda |
| Package readiness | Which source versions will be available by the applicable deadline |
Scope exercise: one question asks FDA to agree to an endpoint, analysis population and missing-data method. Separate the decisions and supporting rationale. Then reassess the meeting type and available time. A Type D request should cover no more than two focused topics and should not need input from more than three disciplines or divisions; a highly complex single topic can still be unsuitable. Fewer question headings cannot cure excessive substantive scope.
Use Table 4 of the final guidance to plan FDA receipt of the package. These are calendar-day timings, and the WRO response time replaces the meeting date where applicable.
| Meeting type | Package timing in Table 4 |
|---|---|
| Type A, Type D and INTERACT | With the meeting request |
| Type C early consultation on a new surrogate endpoint as the primary approval basis in the proposed context | With the meeting request |
| Type B | No later than 30 days before the meeting or WRO response time |
| Type B end-of-phase | No later than 50 days before the meeting or WRO response time, subject to the early-scheduling exception |
| Other Type C | No later than 47 days before the meeting or WRO response time, subject to the early-scheduling exception |
For an end-of-phase meeting scheduled earlier than 70 days from FDA receipt of the request, Table 4 says the package is due no sooner than six calendar days after FDA’s response time for issuing the grant letter. For Type C scheduled earlier than 75 days, the corresponding interval is seven calendar days. Reconcile those exceptions with the actual grant instructions; do not calculate every deadline by blindly subtracting 50 or 47 days from a requested date.
Carry the same question numbering into the background package and preserve FDA’s eventual responses in the meeting follow-up record.
Your preparation checklist
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Frequently asked questions
Do subquestions count toward FDA’s recommended ten-question limit?
Yes. The final guidance recommends no more than ten questions including subquestions and gives each its own number. Count the decisions being asked, not just top-level headings. Keep numbering and scope aligned between the meeting request and package so FDA can trace the supporting information.
Can a Type D meeting cover a complex program if there are only two questions?
Not necessarily. Type D concerns a narrow set of issues, with no more than two focused topics and no more than three disciplines or divisions. Complexity and breadth matter alongside the count. FDA may convert an unsuitable request to the appropriate type; reducing headings does not reduce the underlying review work.
Does requesting written responses remove the meeting-package requirement?
No. The guidance applies its package timelines to WRO as well as other meeting formats. Use the applicable WRO response time and meeting type when planning submission. A request for written answers still needs enough organized evidence for FDA to address the questions.
Can the PDUFA timing table be used for an ANDA or biosimilar meeting?
Do not apply it automatically. This guide addresses the PDUFA meeting framework. Establish the application pathway and relevant GDUFA, BsUFA or other program before selecting meeting types and deadlines. A similar meeting purpose does not establish that the same procedural timetable applies.
Sources and revisions
Requirements, source recommendations and editorial preparation advice have different roles. Review the scope and revision of the source you use.
Guidance
Formal Meetings Between FDA and Sponsors or Applicants of PDUFA Products ↗Final August 2026; §§III–VII and XI. Replaces September 2023 draft. PDF and final-status landing page checked September 22, 2026.
Technical specification · placement only
FDA eCTD v4.0 comprehensive hierarchy ↗Version 2.2, February 2025. Section 1.6. A heading identifies placement, not mandatory applicability.