---
title: "INTERACT meeting"
slug: "interact-meeting"
updated: 2025-05-13T00:37:12Z
published: 2025-05-13T00:37:12Z
canonical: "bgtcplaybook.document360.io/interact-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.

# INTERACT meeting

Welcome to the section on the FDA INTERACT meeting for AAV gene therapies, a potentially beneficial step in the BGTC Regulatory Playbook for companies developing these innovative treatments. INTERACT stands for **IN**itial **T**argeted **E**ngagement for **R**egulatory **A**dvice on **C**BER produc**T**s, and it is one of two early engagement meetings (besides the Pre-IND) that you can have with the FDA Center for Biologics Evaluation and Research (CBER) prior to submitting your IND. [[1]](/v1/docs/ref-interact-meeting)

The INTERACT meeting provides a unique opportunity for sponsors like yourself to engage with the FDA in a pre-submission setting, to discuss key aspects of your development plan and receive early and non-binding feedback on your program. This early feedback can be invaluable in guiding you towards a successful regulatory submission using the BGTC approach and can help to avoid potential delays in the IND process.

In this section, we will provide an overview of the INTERACT meeting, its role in the regulatory process for AAV gene therapies, and how it differs from the Pre-IND meeting. We will also discuss the benefits of participating in this meeting and provide guidance on how to prepare for a successful interaction with the FDA.

## Readiness assessment

Before embarking on this journey, it will be helpful for you to do a readiness assessment. This assessment is designed to ensure you are at an appropriate stage to request a meeting, which can reduce the chances of rejection of the meeting and maximize success. Please click any of the links in the images below to navigate to the different sections.

| [![Person at desk thinking "What is an INTERACT meeting?"](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/image-1738095800794.png)](https://bgtcplaybook.document360.io/docs/what-is-an-interact-meeting) | [![Person at desk thinking "Should I consider an INTERACT meeting?"](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/image-1738095807989.png)](https://bgtcplaybook.document360.io/docs/should-i-consider-an-interact-meeting) | [![Person at desk thinking "I’m convinced! But am I ready for an INTERACT meeting?"](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/image-1738095813568.png)](https://bgtcplaybook.document360.io/docs/am-i-ready-for-an-interact-meeting) | [![Person at desk thinking "I’m doing it!"](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/image-1738095819209.png)](https://bgtcplaybook.document360.io/docs/things-to-be-aware-of-before-continuing) |
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Food and Drug Administration is a U.S. government agency responsible for regulating food, pharmaceuticals, cosmetics, and medical devices

Adeno-associated virus (AAV) - A member of the parvovirus family of single-stranded small DNA viruses that require a helper virus such as adenovirus or herpes simplex virus for replication. AAV vectors are the leading platform for gene delivery for the treatment of a variety of human diseases.

Bespoke Gene Therapy Consortium (BGTC) - An AMP that aims to develop platforms and standards that will speed the development and delivery of customized or 'bespoke’ gene therapies that could treat the millions of people affected by rare diseases.

Center for Biologics Evaluation and Research (CBER) - The Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.