---
title: "Post-meeting follow-up"
slug: "post-meeting-follow-up-1"
tags: ["Pre-IND meeting"]
updated: 2025-05-09T17:45:38Z
published: 2025-05-09T17:45:38Z
canonical: "bgtcplaybook.document360.io/post-meeting-follow-up-1"
---

> ## Documentation Index
> Fetch the complete documentation index at: https://bgtcplaybook.document360.io/llms.txt
> Use this file to discover all available pages before exploring further.

# Post-meeting follow-up

In this section, your goal is to provide the FDA with information related to meeting minutes. After your Pre-IND meeting, the FDA will issue meeting minutes summarizing the content discussed, 30 days after the meeting. The purpose of this is to give you the opportunity to review what was discussed. If there are any aspects that you disagree with in the minutes, then you can request clarification or suggest changes (which the FDA may or may not agree with). It is important to note that responses to these minutes will have to be included in the IND submission, and the contents need to be addressed in the actual drug development period between Pre-IND and IND submission. You can find an example of the meeting minutes/summary linked here: [MSD Pre-IND FDA meeting summary](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/MSD_pre-IND%20Meeting_FDA%20Meeting%20Summary_Redacted_25Mar2025_Redacted.pdf).

It is highly recommended that you also write your own meeting minutes and provide them to the FDA right after the meeting, as this is helpful to the Agency and can also further accelerate the process. It is also recommended to log your interaction minutes and develop a game plan for how you plan to address/modify plans as needed, or to prepare for the next interaction with the FDA on topics as warranted.

Investigational New Drug Application (IND) - An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.

An IND must be authorized prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application.