FDA Type B vs Type C meeting preparation checklist

The right FDA meeting is the one that matches the development decision the sponsor needs to make. A meeting request should not be used to transfer an unresolved internal debate to the agency. Before choosing a Type B or Type C interaction, define the decision, the sponsor’s position, the supporting evidence, the remaining uncertainty, and what will change based on FDA’s response.

FDA’s meeting guidance and granted-meeting communication control the applicable procedures and timing. Verify the current status of relevant guidance, center-specific practices, and the instructions in the agency’s response before submitting a request or package.

1. Decide whether the question belongs in a Type B or Type C meeting

Also consider whether the issue is better suited to a Type A, Type D, INTERACT, written communication, application amendment, or another center-specific interaction. FDA’s current resources should be consulted for the available options.

2. Write the decision statement before the meeting request

Use one page internally to establish:

• The regulatory and development decision that must be made.
• The date by which the decision is needed and the consequence of delay.
• The sponsor’s proposed approach and the strongest evidence supporting it.
• The material uncertainty or disagreement that FDA feedback should resolve.
• The alternative path if FDA does not agree.

If the team cannot write this clearly, the meeting questions and package are not ready.

3. Build a complete, disciplined meeting request

FDA’s public pre-IND resources emphasize a clear objective, agenda, specific questions grouped by discipline, participants, indication, dosing information, manufacturing summary, and development-plan context. A strong request generally includes:

• Product, application, indication, development stage, and relevant regulatory history.
• The requested meeting type and format with a concise justification.
• One primary objective and a limited set of supporting objectives.
• A proposed agenda mapped to the questions and decision owners.
• Specific questions grouped logically across CMC, nonclinical, clinical, statistics, clinical pharmacology, or other relevant disciplines.
• Sponsor participants, requested FDA disciplines, and any essential external experts.
• Proposed dates and required administrative information under the applicable guidance.

4. Write questions that can produce useful feedback

A productive regulatory question usually contains four elements:

1. Context: the decision and why it matters now.
2. Sponsor position: the approach the sponsor proposes to take.
3. Evidence: the data, precedent, analysis, or rationale supporting that approach.
4. Question: a direct request for agreement or specific feedback.

Avoid questions that are excessively broad, combine several decisions, ask FDA to design the program, omit the sponsor’s position, or depend on data that will not be available in the package.

5. Build the package around the questions

The package is not a collection of every document the team has produced. It is the evidence needed to understand and answer the questions. For each question, verify that:

• The executive summary, background, question text, data displays, and sponsor conclusion tell the same story.
• Material limitations and contrary evidence are visible rather than buried.
• Tables and figures can be understood without searching across several sections.
• Terminology, product identifiers, dose, formulation, study status, and version dates are consistent.
• Cross-functional implications are reconciled—for example, whether CMC comparability affects clinical interpretation.
• The proposed approach is operationally possible within the program timeline.

6. Run a formal cross-functional challenge

Before finalization, conduct a challenge session independent of routine document review. Ask:

• What would a skeptical reviewer identify as the weakest assumption?
• Which question is most likely to receive a conditional or noncommittal response?
• Is the sponsor asking for agreement before the evidence is mature enough?
• Could FDA interpret any figure or statement differently from the sponsor?
• What new request could follow from each identified uncertainty?
• What can the team concede without undermining the primary objective?

7. Rehearse the interaction as a decision meeting

Assign a meeting lead, question owners, subject-matter responders, a timekeeper, and a note owner. Rehearse concise initial responses and likely follow-ups. The team should know:

• Who speaks first for each question and who may supplement.
• Which facts are confirmed, which remain estimates, and which should not be asserted.
• Which alternative approaches are acceptable.
• Who has authority to make or defer an internal decision during the interaction.
• How the team will capture agency advice, commitments, conditions, and unresolved points.

8. Convert FDA feedback into controlled follow-through

After the interaction, reconcile notes promptly and compare the agency feedback with the sponsor’s original decision statement. Track each item as one of the following:

• Agreement or advice requiring no plan change.
• Conditional agreement with a defined evidence requirement.
• New work, analysis, study, or document required.
• Open question requiring clarification or a future interaction.
• Internal decision that remains with the sponsor.

Update the program plan, risk register, evidence strategy, and decision log. The value of the meeting is realized only when the feedback changes controlled execution.