---
title: "How to request a formal FDA meeting?"
slug: "how-to-request-a-formal-fda-meeting"
updated: 2025-05-15T17:17:26Z
published: 2025-05-15T17:17:26Z
canonical: "bgtcplaybook.document360.io/how-to-request-a-formal-fda-meeting"
---

> ## Documentation Index
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> Use this file to discover all available pages before exploring further.

# How to request a formal FDA meeting?

When requesting a meeting, a written request must be submitted to the FDA through the appropriate pathway (electronic or paper submission) and to the respective review division or office. To get more information around eCTD requirements and exceptions, please refer to the FDA guidance: Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications: [https://www.fda.gov/media/135373/download](https://www.fda.gov/media/135373/download).

It is important to ensure that the meeting request includes adequate information for the FDA to assess the objective of the meeting and identify the appropriate members needed to discuss the proposed agenda items. Key items that the meeting request must include are:

- The proposed meeting format
- The date you anticipate sending the meeting background package to the FDA by
- Brief statement showcasing the purpose of the meeting

Pro tip:

In the meeting request, you should include a summary of completed or upcoming studies and/or data that you intend to discuss at the meeting. Additionally, it is recommended that you include a summary table highlighting the major results, enough to facilitate the discussion and provide high level information on the study designs. The table below is a generic example of what this table should include. You can choose to combine past and future studies into a single table or separate into different tables and may wish to add more information columns if meaningful. *(See example table below)*

| Study Name | Objectives | Design | Results |
| --- | --- | --- | --- |
| *Completed Study ABC* | Proof of Concept – Biological Activity | Brief description of treatment and control groups, number, dose, time points, assessments | Gene therapy demonstrated treatment effects (provided description) |
| *Completed Study XYZ* | Proof of Concept – Dose Range Finding | Brief description of treatment and control groups, number, dose, time points, assessments | Gene therapy demonstrated therapeutic activity in the following doses: X, Y, Z |
| *Future Study ABC* | Pilot Animal Study - Pharmacology | Brief description of treatment and control groups, number, dose, time points, assessments | To be confirmed |
| *Future Study XYZ* | GLP Animal Study - Safety | Brief description of treatment and control groups, number, dose, time points, assessments | To be confirmed |

- List of specific objectives and areas of input, and outcomes expected from the meeting
- Proposed agenda with the estimated time needed for each discussion item
- List of planned attendees from the sponsors’ side – including their names and titles

Pro tip:

Requesting for the FDA staff who are not essential to the review process can affect the ability to hold the meeting within the proposed time frame of the meeting type. Thus, while requesting the attendance of a nonessential FDA staff, you should provide justification for their attendance and state whether a later meeting will be acceptable to accommodate the attendees.

Some of the other things that a meeting request can include are:

- Application number
- Product name
- Chemical name, established name, and/or structure
- Proposed regulatory pathway
- Proposed indications
- Dosage form, route of administration (ROA)
- Pediatric study plans or human factors engineering plans (if any)
- List of proposed questions, grouped by the FDA discipline, and a brief explanation for the purpose of each question.

Overall, it is important for you to define the specific areas of input needed from the FDA. In case there is a change in the planned attendees between the request and the meeting, please provide the FDA with an updated list of attendees (names, titles, and affiliations).

Electronic Common Technical Document (eCTD) - The standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

Good Laboratory Practice (GLP) - is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.