Abstract

François-Xavier Lacasse*

ABSTRACT

Engaging the FDA early has become indispensable for developers of novel molecular entities/pharmaceutical; technologies seeking to manage/mitigate risk and accelerate progress. The INTERACT program (INitial Targeted Engagement for Regulatory Advice on CBER/CDER Products) provides sponsors with early access to regulatory input on preclinical programs, particularly in emerging modalities and critical areas such as chemistry, manufacturing and controls, toxicology program that will support further clinical program and the writing of investigational new drug application (IND). In this short communication will be reviewed the regulatory role of INTERACT meetings and highlight strategies to maximize their impact. Since new molecular entities, whether they are chemicals, biologics, or new drug delivery systems, are becoming increasingly challenging, it can be concluded that INTERACT meetings are a decisive tool for achieving strategic clarity, preventing costly delays, and reinforcing confidence among stakeholders and investors.