By Ann Leonard
In October 2018, the Food and Drug Administration (FDA) issued Standard Operating Policy and Procedure (SOPP) – SOPP 8214 Version 1.0: INTERACT Meetings with Sponsors for Drugs and Biological Products. This document details recommendations for the Center for Biologics Evaluation and Research (CBER)’s engagement with sponsors (such as industry and investigators) in an early development discussion of a new biologic product.
This new procedure outlines the process of engaging in an INitial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) meeting with CBER representatives in order to gain informal, preliminary consultation on development-related issues across a wide range of aspects of the development program.
Read how the INTERACT meeting can be an invaluable engagement with the agency to inform the successful planning and execution of a novel product development program.