Pre-IND Meeting Preparation Guide

What a pre-IND meeting is

A pre-IND meeting is an early, optional interaction with the FDA review division that will eventually receive the IND. It exists so sponsors can confirm assumptions about IND-enabling studies, CMC scope, and clinical design before committing to the submission.

When to request one

The meeting is most useful when at least one decision in the program would meaningfully change based on FDA input — for example, an unusual species selection, a complex first-in-human design, or a novel modality where prior precedent is thin.

Briefing-package contents

The briefing package should be focused enough that a reviewer can answer the questions asked without reconstructing the program. Typical sections include program summary, nonclinical overview, CMC overview, draft clinical protocol synopsis, and a numbered question list.

Eight-step preparation sequence

1. Define the program decisions FDA input would change.
2. Draft three to seven focused questions tied to those decisions.
3. Assemble nonclinical, CMC, and clinical evidence behind each question.
4. Write a concise program summary and indication context.
5. Internally pressure-test the briefing package for clarity and gaps.
6. Run a mock review with reviewers who did not write the package.
7. Refine questions based on what the mock review surfaces.
8. Submit the meeting request and briefing package on the planned timeline.

Question framing

The strongest pre-IND questions are specific, actionable, and tied to a position the sponsor has already taken. Open-ended questions tend to produce general feedback that does not move the program forward.

Mock-review practice

A mock review by reviewers outside the writing team often surfaces the same gaps a real reviewer would. This is where AI-assisted regulatory readiness workflows can help by structuring the review and highlighting likely question areas.

Frequently asked questions