Written by: By Blaine VanLeuven, Executive Director RSD– August 2025
The FDA encourages sponsors to seek guidance from the FDA throughout the course of development to maximize the likelihood of regulatory approval.
Early in development, sponsors can request an (Initial Targeted Engagement for Regulatory Advice) meeting.
Key reasons to request an INTERACT meeting:
- Early Feedback: Gain insight into the regulatory expectations and potential pathways for the product before investing in expensive and time-consuming development.
- Identify Potential Roadblocks: The FDA can point out scientific, technical, or CMC (chemistry, manufacturing, and controls) issues that may delay progress if not addressed.
- Address Novel Challenges: Receive guidance about novel or challenging issues avoiding delays in product development.
- Receive Advice on Study Design: Get advice regarding pre-clinical study design, assay development, and/or first-in-human trial planning.
- Accelerate Development: With clearer expectations, and less unknowns/variables, companies can streamline the path to IND-enabling efforts and reduce time to IND (Investigational New Drug application).
When to request an INTERACT Meeting:
An INTERACT meeting is best requested once the investigational product to be evaluated in a clinical study has been identified. At this point, some preliminary pre-clinical proof-of-concept studies with the intended product should already be completed. However, definitive toxicology studies should not yet be designed or conducted. Similarly, the manufacturing process that will be used for clinical studies does not need to be finalized, and assays along with preliminary lot release criteria may still be in early stages of development.
Key durations of an INTERACT Meeting:
How to Prepare for an INTERACT meeting:
- Define Your Goal
Think of the INTERACT meeting as a chance to ask focused questions and get regulatory clarity. Define 2–4 key topics you need feedback on (e.g., pre-clinical study design, CMC challenges, or first-in-human considerations). - Keep It Focused
Your briefing document should be clear, brief, and to the point. Include enough background to make your questions understandable, but don’t overwhelm the reviewers with data. Bullet points are your friend. - Frame Good Questions
The best questions are specific and answerable. Instead of “Is our pre-clinical plan, okay?” ask, “Does the FDA have concerns about using [X model] to evaluate [Y outcome]?” - Don’t Expect Final Answers
INTERACT meetings are informal and non-binding. Think of it more as a directional compass than a checklist. - Be Open to Feedback
Sometimes the FDA may challenge your approach or ask for more data. That’s a good thing, it’s better to hear that now than during a formal review or after you have invested dollars and hours in pre-clinical studies. - Practice
INTERACT meetings are typically short (~1 hour). Practice staying on topic so you can cover all your key questions.
Final Thoughts
The INTERACT process can feel a bit mysterious the first time through, but it’s truly designed to help you. Think of it as an early conversation with a very important stakeholder, one that wants you to succeed and keep patients safe.
If you’re in the early stages of product development and wondering what the FDA might think about your approach or if your product doesn’t fit neatly into existing categories, this meeting could give you clarity, confidence, and a stronger path forward.
The FDA feedback will provide a roadmap for your next steps!