Regulatory Workspace

INTERACT is an INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs and is held early in development to align on key questions.

Conduct the INTERACT meeting and capture advice, decisions, and next‑step actions.

Convert meeting minutes into a regulatory plan on what FDA expects to see next (e.g., specific nonclinical justifications, immunogenicity assessment plan, comparability acceptance conditions, documentation for OUS data).

Establish data standards and submission tooling early to reduce friction.

High-level screen for accelerated programs and suitability conditions.

Kick off Type B pre-IND process and align on key questions.

Prepare for pre-IND/IND engagement with FDA, including briefing package and questions.

Module 3 documents the manufacturing process, control strategy, specifications, and analytical methods supporting the drug substance (3.2.S) and drug product (3.2.P). Compile and finalize Module 3 (Quality) per ICH M4Q guidelines.