---
title: "Introduction, purpose, and objective of the meeting"
slug: "introduction-purpose-and-objective-of-the-meeting"
updated: 2025-04-24T22:53:54Z
published: 2025-04-24T22:53:54Z
canonical: "bgtcplaybook.document360.io/introduction-purpose-and-objective-of-the-meeting"
---

> ## 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.

# Introduction, purpose, and objective of the meeting

### **Introduction**

In this section, you will introduce your product to the FDA by providing a summary of your investigational product and the proposed indication. To simplify the process, consider breaking your introduction into four sections as shown in figure below. Additionally, a description of what information you should consider adding under each section is provided.

| Product name/Code | Proposed Indications | Product Description | Dosage |
| --- | --- | --- | --- |
| State product name or sponsor code; include application number if available | Specify what indications the product is intended for | Provide a brief description of all components of the final product, including chemical name and structure | Outline dosing regimen, dosage form, and route of administration |

### **Purpose and objective of the meeting**

In this section, you will be providing a brief statement summarizing what you intend to discuss with the FDA. Consider including the following in your statement:

1. The types of completed or planned studies/data that you intend to discuss
2. The general nature of the critical questions to be asked
3. Where the meeting fits in overall development plans
4. A list of the specific objectives/outcomes from the meeting