INTERACT-The Who, What, When, Where and Why in Regulatory Workstream
INTERACT stands for Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products. FDA describes an INTERACT meeting as an opportunity for sponsors to obtain early feedback on novel products and development programs before an IND is submitted. The sponsor should generally have identified the investigational product and conducted preliminary preclinical proof-of-concept work but should not yet have designed and conducted definitive toxicology studies.
FDA specifically notes that INTERACT meetings are intended to help address unique or challenging issues that could otherwise delay development toward the clinic.
Who Is INTERACT intended for?
INTERACT stands for Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products. It is intended for sponsors developing novel therapies who need early FDA feedback on significant or challenging development questions.
For products regulated by CBER's Office of Therapeutic Products (OTP), FDA provides specific INTERACT procedures. FDA also identifies INTERACT as an early engagement option for CBER/CDER products.
What is the significance of INTERACT in regard to Regulatory Operations?
An INTERACT meeting is an early-stage regulatory interaction with FDA before an IND is submitted.
It is designed for focused questions involving potentially challenging aspects of a novel development program—for example:
Preclinical development
IND-enabling studies
Novel product characteristics
CMC considerations
Manufacturing approaches
Clinical development considerations
Other issues that could create significant development challenges
The meeting is not intended to replace a Pre-IND meeting. Instead, it provides an earlier opportunity to obtain targeted FDA feedback.
When should Regulatory Operation utilize INTERACT?
Timing is one of the most important aspects of INTERACT.
FDA says the appropriate time is generally when the sponsor:
1. Has identified the investigational product
2. Has conducted preliminary preclinical proof-of-concept studies
3. Has NOT yet designed and conducted definitive toxicology studies
That makes INTERACT essentially a “pre-Pre-IND” opportunity in the development timeline.
For OTP INTERACT meetings, FDA currently indicates:
Milestone | FDA Timeline |
FDA decision on meeting request | 21 days |
Meeting scheduled / written response | Within 75 days |
Meeting package | Due with meeting request |
Meeting duration | 60 minutes |
FDA preliminary responses | No later than 5 days before meeting |
Where can regulatory agencies access INTERACT services?
INTERACT is an FDA–sponsor regulatory interaction, generally conducted virtually/through FDA's established meeting process rather than as a public meeting.
The specific FDA center and submission instructions depend on the product.
For CBER/OTP-regulated products, FDA provides instructions for submitting the meeting request through OTP. For a CDER-regulated product, FDA directs sponsors to contact CDER for instructions.
Why in INTERACT valuable to the regulatory workstream?
The purpose is to give sponsors an opportunity to address important development questions early—before they become larger development obstacles.
FDA describes INTERACT as an opportunity for sponsors developing first-in-human novel therapies to seek feedback before a Pre-IND meeting and before submitting an IND.
The practical objective is:
Identify the issue early → Ask FDA targeted questions → Receive feedback → Incorporate feedback into development planning
This can be particularly valuable for novel or technically complex products, where conventional development approaches may not adequately address the product's unique characteristics.
This is the part that makes INTERACT especially relevant to your Regulatory Operations audience.
An INTERACT meeting isn't just a meeting. It creates a regulatory workstream.
Before the meeting
Regulatory Strategy
↓
Cross-functional questions
↓
CMC / Nonclinical / Clinical inputs
↓
Meeting package development
↓
QC & reconciliation
↓
FDA submission
FDA recommends that INTERACT questions be clearly worded and targeted. For a 60-minute meeting, FDA considers a maximum of 10 questions, including sub questions, reasonable.
After the meeting
FDA Feedback
↓
Meeting documentation
↓
Action items
↓
Development plan updates
↓
IND planning
The Simple Takeaway
INTERACT gives sponsors an opportunity to engage FDA early—before an IND and before definitive toxicology studies—to address targeted questions that could affect the development path.
For Regulatory Operations:
INTERACT isn't just about preparing for an FDA meeting. It's about turning early FDA feedback into an organized, actionable development and submission plan.
The Sugar Water Operations Team Helping emerging biotech companies turn complex regulatory requirements into organized, submission-ready operations.
Contact SWOT at info@sugarwaterops.com for additional questions regarding submission readiness and assistance establishing a controlled process for proper planning and collecting data.