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