---
title: "Module 2: Summary documents"
slug: "module-2-summary-documents"
description: "IND Submission Summary Documents"
updated: 2025-04-24T23:08:06Z
published: 2025-04-24T23:08:06Z
canonical: "bgtcplaybook.document360.io/module-2-summary-documents"
---

> ## 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.

# Module 2: Summary documents

## Module 2.2: Introduction to Summaries

In this section, you will be providing the FDA with a summary of the development plans, non-clinical and any clinical data obtained on the investigational product. Ideally, the introduction should include basic information like proprietary, nonproprietary, and common names of your product, company name, formulation of the dosage form, strengths, route of administration, and proposed indications.

Consider following the sample outline below while structuring your introduction based on the information you have available:

- Product Name
- Product Description
  - Active Ingredients
  - Pharmacological Class
- Proposed Indication
- Formulation of the Dosage Form
- Route of Administration
- Clinical Program Objectives
- Planned Duration of the Proposed Clinical Study
- References