This is a ready-to-use checklist. Work through each item before a meeting package or briefing document is released to a health authority. Mark each item Pass, Fail, or N/A, record the evidence location, and resolve every Fail before submission. A filled specimen follows. Verify package structure and timing against the current guidance for your meeting type.
How to use
- Run this before the package is finalized, not after.
- Any Fail blocks release until corrected or justified.
- The reviewer signing the checklist is accountable that each Pass is real, not assumed.
Section A: Administrative and structure
| # | Item | Pass / Fail / N/A | Evidence / location |
|---|---|---|---|
| A1 | Cover / application information complete (product, IND/NDA/BLA/MAA number, meeting type, requested format, contacts) | <<FILL>> | |
| A2 | Meeting type matches the trigger and is stated correctly | <<FILL>> | |
| A3 | Package structure follows the current guidance for this meeting type | <<FILL>> | |
| A4 | Attendee list complete with names, titles, affiliations, and disciplines; requested agency disciplines stated | <<FILL>> | |
| A5 | Package within the page / format expectations; all cross-references resolve | <<FILL>> | |
| A6 | Submission deadline for this meeting type confirmed and met | <<FILL>> |
Section B: Product background
| # | Item | Pass / Fail / N/A | Evidence / location |
|---|---|---|---|
| B1 | Indication, mechanism, and development stage stated concisely | <<FILL>> | |
| B2 | Prior agency interactions and their outcomes summarized accurately | <<FILL>> | |
| B3 | Regulatory designations (fast track, breakthrough, orphan, RMAT, PRIME) stated correctly | <<FILL>> |
Section C: Question quality (the core)
| # | Item | Pass / Fail / N/A | Evidence / location |
|---|---|---|---|
| C1 | Questions grouped by discipline | <<FILL>> | |
| C2 | Each question states the issue and context briefly | <<FILL>> | |
| C3 | Each question gives the sponsor’s proposed approach and rationale | <<FILL>> | |
| C4 | Each question ends with a closed ask (“Does the Agency agree that X is acceptable to support Y?”), not an open one | <<FILL>> | |
| C5 | Questions are prioritized; the number is focused, not padded | <<FILL>> | |
| C6 | Each question cites the relevant standard / guidance where one applies | <<FILL>> |
Section D: Data support
| # | Item | Pass / Fail / N/A | Evidence / location |
|---|---|---|---|
| D1 | Each position is supported by the data referenced in the package | <<FILL>> | |
| D2 | Nonclinical, clinical, CMC, and statistical summaries are consistent with the source documents | <<FILL>> | |
| D3 | Tables and figures are accurate and self-explanatory | <<FILL>> |
Section E: Quality, validation, and inspection statements (must be true)
| # | Item | Pass / Fail / N/A | Evidence / location |
|---|---|---|---|
| E1 | Every statement about validation status is accurate and dated; nothing is overstated as “complete” | <<FILL>> | |
| E2 | Every statement about data integrity controls is accurate | <<FILL>> | |
| E3 | GMP / facility status and inspection history are stated accurately, including open observations | <<FILL>> | |
| E4 | Any quality-system commitment in the package is backed by a credible, dated plan | <<FILL>> | |
| E5 | QA has reviewed and signed off on sections E1 to E4 | <<FILL>> |
Section F: Internal control
| # | Item | Pass / Fail / N/A | Evidence / location |
|---|---|---|---|
| F1 | All discipline sections reviewed by their SME owners | <<FILL>> | |
| F2 | Positions and fallback commitments approved per the internal approval matrix | <<FILL>> | |
| F3 | A single regulatory lead owns the package, agenda, and minutes | <<FILL>> |
Signoff
| Field | Entry |
|---|---|
| Program / application | <<FILL>> |
| Meeting type | <<FILL>> |
| Total Fails open at review | <<FILL: must be 0 at release>> |
| Reviewer (name, signature, date) | <<FILL>> |
| QA reviewer (name, signature, date) | <<FILL>> |
| Regulatory lead approval (name, signature, date) | <<FILL>> |
References
FDA Guidance for Industry, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (current revision). EMA procedural guidance on scientific advice and protocol assistance. ICH M4 (CTD / eCTD) for supporting-data structure.
Confirm current package structure and timing for your meeting type before relying on this checklist.
Filled specimen
The following shows Section C and the signoff completed for an example end-of-phase-2 (Type B(EOP)) package. Illustrative only.
| # | Item | Pass / Fail / N/A | Evidence / location |
|---|---|---|---|
| C1 | Questions grouped by discipline | Pass | Clinical Q1-3, CMC Q4-5, Stats Q6 |
| C2 | Each question states issue and context | Pass | Background paragraph per question |
| C3 | Sponsor approach and rationale given | Pass | Position stated per question |
| C4 | Closed ask | Fail then Pass | Q4 originally “What are the Agency’s expectations for comparability”; rewritten to “Does the Agency agree the ICH Q5E comparability data support the site change without clinical bridging?” |
| C5 | Prioritized, focused | Pass | 6 questions, milestone-relevant only |
| C6 | Cites relevant standard | Pass | Q4 cites ICH Q5E; Q6 cites the SAP |
| Field | Entry |
|---|---|
| Program / application | Compound X-19, end-of-phase-2, IND 142xxx |
| Meeting type | Type B(EOP) |
| Total Fails open at release | 0 (Q4 corrected before submission) |
| Reviewer | A. Lindgren, signed, 11 May 2026 |
| QA reviewer | R. Gomez, signed, 12 May 2026 |
| Regulatory lead approval | J. Okafor, signed, 12 May 2026 |
The single Fail caught here, an open-ended comparability question, is the most common package defect: it would have drawn a non-committal answer the sponsor could not use. Rewriting it to a closed ask is what made the meeting productive.
Common inspection findings this checklist prevents
- A package that overstated validation or facility readiness, contradicted later at inspection.
- Open-ended questions that produced advice the program could not rely on.
- A package submitted late or incomplete, causing the meeting to be cancelled or rescheduled.
How to adapt this checklist
- Replace the package-structure expectations with those of the current guidance for your meeting type.
- Insert your internal approval matrix reference in F2.
- Add discipline-specific rows where your program has unusual content (for example a companion diagnostic or a combination product constituent).