This is a ready-to-use checklist for requesting a formal FDA meeting (Type A, B, C, or D) and assembling the briefing package that goes with it. Work each item to Yes, N/A with rationale, or a documented gap before the request goes to the agency. Replace every <<FILL: ...>> placeholder. A filled specimen for a pre-IND Type B meeting follows. Confirm the current guidance and its exact day counts before you rely on them; the FDA revises these timelines periodically.
Checklist control
| Field | Entry |
|---|---|
| Checklist number | <<FILL: CHK-ID>> |
| Product / candidate | <<FILL: candidate code, no confidential name>> |
| Proposed meeting type | Type A / Type B / Type C / Type D / INTERACT |
| Meeting purpose (one line) | <<FILL: e.g. pre-IND, end-of-Phase-2, pre-NDA/BLA, dispute resolution>> |
| Target meeting date | <<FILL>> |
| Completed by | <<FILL>> |
Section 1: Meeting type selection
| # | Item | Status (Y / N / NA) | Evidence / rationale |
|---|---|---|---|
| 1.1 | The meeting purpose matches the definition of the selected type (Type A: urgent/stalled program; Type B: a defined milestone; Type C: other development/review topic; Type D: one or two narrow, focused questions; INTERACT: early, informal, CBER product with no established reference point) | <<FILL>> | <<FILL>> |
| 1.2 | A less urgent type was ruled out with a stated reason (Type A is not requested for a routine question) | <<FILL>> | <<FILL>> |
| 1.3 | The correct FDA response-time and scheduling-window expectations for this type are known and built into the program timeline | <<FILL>> | <<FILL>> |
Section 2: Meeting request letter
| # | Item | Status | Evidence / location |
|---|---|---|---|
| 2.1 | Product name/code, application number (if one exists), and indication stated | <<FILL>> | <<FILL>> |
| 2.2 | Meeting type requested, stated explicitly and matched to Section 1 | <<FILL>> | <<FILL>> |
| 2.3 | Brief statement of the purpose and the specific milestone or question driving the request | <<FILL>> | <<FILL>> |
| 2.4 | List of specific questions to be discussed (high-level; full questions go in the package) | <<FILL>> | <<FILL>> |
| 2.5 | Proposed attendees and their roles, both sponsor and any requested FDA disciplines | <<FILL>> | <<FILL>> |
| 2.6 | Proposed date(s) and format (in person, teleconference, or written response only) | <<FILL>> | <<FILL>> |
| 2.7 | Prior related submissions referenced (IND/BLA/NDA number, prior meeting minutes) | <<FILL>> | <<FILL>> |
Section 3: Briefing package content
| # | Item | Status | Evidence / location |
|---|---|---|---|
| 3.1 | Background: development history, regulatory history, and why this meeting is needed now | <<FILL>> | <<FILL>> |
| 3.2 | Specific questions, each stated as a direct, answerable question, not a topic heading | <<FILL>> | <<FILL>> |
| 3.3 | For each question, the sponsor’s own proposal or position, not just the question itself | <<FILL>> | <<FILL>> |
| 3.4 | Supporting data package for each question (nonclinical summary, CMC summary, clinical data, statistical analysis plan, as applicable) | <<FILL>> | <<FILL>> |
| 3.5 | Summary tables and figures are self-contained and do not require the full study report to interpret | <<FILL>> | <<FILL>> |
| 3.6 | Package length and format follow current FDA meeting-package guidance | <<FILL>> | <<FILL>> |
| 3.7 | Internal cross-functional review completed (regulatory, clinical, CMC, nonclinical, biostatistics, QA as relevant) before submission | <<FILL>> | <<FILL>> |
Section 4: Timing
| # | Item | Status | Evidence / location |
|---|---|---|---|
| 4.1 | Meeting request submitted with enough lead time for the applicable type’s scheduling window | <<FILL>> | <<FILL>> |
| 4.2 | Briefing package submission date set against the applicable deadline for the granted meeting type (commonly 30 days before a general Type B meeting, 50 days before a Type B end-of-Phase meeting, 47 days before Type C; confirm current guidance for Type A and Type D) | <<FILL>> | <<FILL>> |
| 4.3 | Internal drafting and review timeline works backward from the package deadline, not from the meeting date | <<FILL>> | <<FILL>> |
| 4.4 | Contingency plan if FDA grants a written-response-only meeting instead of a live discussion | <<FILL>> | <<FILL>> |
Section 5: Pre-meeting and post-meeting logistics
| # | Item | Status | Evidence / location |
|---|---|---|---|
| 5.1 | Internal dry run / mock meeting held with the full sponsor team | <<FILL>> | <<FILL>> |
| 5.2 | A designated note-taker and a designated lead spokesperson per topic are assigned | <<FILL>> | <<FILL>> |
| 5.3 | Draft meeting minutes prepared promptly after the meeting and submitted to FDA per the applicable timeline | <<FILL>> | <<FILL>> |
| 5.4 | Agreements and action items from the minutes are logged in the health-authority interaction record and assigned owners | <<FILL>> | <<FILL>> |
| 5.5 | Any FDA disagreement or unresolved question is escalated internally with a documented plan, not left ambiguous | <<FILL>> | <<FILL>> |
Acceptance criteria
- The requested meeting type matches its formal definition, and a more urgent type was not requested to shortcut the queue for a routine question.
- Every question in the briefing package is a specific, answerable question, each paired with the sponsor’s own proposed position.
- The package reaches the agency by the deadline that applies to the granted meeting type, counted backward from the confirmed meeting date, not from the request date.
- Minutes are drafted and logged promptly, and every agreement becomes a tracked commitment, not just a paragraph in a file.
Common gaps this checklist prevents
- Requesting Type A treatment for a question that does not meet the urgent/stalled-program bar, which gets reclassified and resets the clock.
- A briefing package that describes background at length but never states a direct, answerable question.
- A package submitted late against the applicable deadline for the granted meeting type, which risks a written-response-only outcome instead of a live discussion.
- Meeting agreements that exist only in someone’s notes and never make it into the submission or the interaction log.
- Sending a cross-functional team into the meeting with no assigned lead per topic, so the sponsor answers a question inconsistently across speakers.
How to adapt this checklist
- Set the checklist number, candidate code, and proposed meeting type in the control block.
- For an INTERACT meeting, replace Section 3’s items with CBER’s informal-meeting expectations, since the format is lighter than a formal briefing package.
- Confirm the current FDA guidance for meeting types and package-submission deadlines before every use; these windows are revised periodically and this checklist states the timelines current as of publication.
- Route the completed package through the same cross-functional review your organization uses for a marketing application, at a scale proportional to the meeting’s stakes.
Filled specimen
Illustrative extract for a pre-IND Type B meeting request. Candidate and dates are examples.
| Field | Entry |
|---|---|
| Proposed meeting type | Type B (pre-IND) |
| Meeting purpose | Align nonclinical package, first-in-human dose, and CMC plan ahead of IND submission |
| Target meeting date | 14 weeks from request |
| # | Item | Status | Evidence / location |
|---|---|---|---|
| 1.1 | Purpose matches Type B (a defined milestone: pre-IND) | Y | Request letter section 1 |
| 2.4 | Specific questions listed: is the proposed first-in-human starting dose acceptable; is the 28-day GLP toxicology package sufficient to support a 14-day clinical dosing regimen; does the proposed CMC comparability plan for the Phase 1 process meet expectations | Y | Request letter section 3 |
| 3.2 | Each question restated in the package with the sponsor’s own proposed answer attached, not left open | Y | Briefing package sections 4.1-4.3 |
| 4.2 | Package submitted 30 days before the confirmed meeting date, per the general Type B deadline | Y | Submission log, package filed 14 Aug 2026 for a 13 Sep 2026 meeting |
| 5.3 | Draft minutes submitted to FDA within 2 business days of the meeting for concurrence | Y | Minutes filed 15 Sep 2026 |
The question on CMC comparability drew a written FDA comment during concurrence, refining the sponsor’s proposed process-change threshold; the refined position was captured in the final minutes and carried forward into the IND’s CMC section, which is the entire point of holding the meeting before submission rather than finding out during review.