Definition
An INTERACT meeting is an early-stage, informal discussion between drug sponsors and the FDA, intended to provide non-binding feedback on a sponsor’s development plan for novel products. These meetings occur prior to filing an IND and focus on key questions related to manufacturing (CMC), toxicology, and early clinical design. Sponsors use this opportunity to clarify strategy, address concerns, and potentially avoid unnecessary studies by receiving targeted advice on innovative products. The issues discussed often relate to IND requirements, including the design of IND-enabling toxicity studies (such as species selection and endpoints), complex manufacturing technologies or processes, development of innovative devices used with drugs or biologics, and the use of cutting-edge testing methodologies.TEST
Purpose
- To de-risk and accelerate development by getting early insight into the evidence needed for a future regulatory pathway.
Common Characteristics
- Early Stage: Occurs before definitive toxicology studies but after initial product identification and proof-of-concept.
- Informal & Non-Binding: Feedback is guidance, not official decisions, and formal meeting minutes aren't issued, though sponsors prepare detailed summaries.
- Focused Questions: Sponsors submit concise packages (around 10 pages) with 3-5 specific, tightly worded questions to get targeted input.
Consider Bringing
- Cover Letter: State it's an INTERACT request.
- Product Intro: Concise description of the product, disease, etc.
- Key Questions: 3-5 focused questions with context.
- Data Summary: Preclinical, CMC info, and future plans.
- Participants: List of attendees from your side.
How it Differes from Pre-IND Meetings:
- INTERACT: Earlier, more exploratory, focused on initial strategies, often for novel/complex products.
- Pre-IND: More detailed, focuses on data needed for the actual IND submission (e.g., IND-enabling studies).