FDA In Brief > FDA In Brief: FDA announces program to enhance early communications with biological product developers

FDA In Brief > FDA In Brief: FDA announces program to enhance early communications with biological product developers



FDA In Brief: FDA announces program to enhance early communications with biological product developers

The FDA’s new INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) meeting program was created to facilitate early interactions between sponsors and CBER staff. It replaces the existing CBER pre- pre-Investigational New Drug (IND) meeting process for all products across the center. These meetings will allow sponsors that are not yet ready for a pre-IND meeting to receive feedback from CBER. INTERACT meetings will enable sponsors to engage with the FDA early in the development process and obtain advice on a wide range of development-related topics. INTERACT meetings can be used to clarify CBER’s expectations regarding product development programs and to help facilitate more efficient product development. Continue reading...