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 INitial Targeted Engagement for Regulatory Advice on CBER producTs, 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]
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.
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