Big Molecule Watch
June 27, 2018

FDA Announces Early Communications Program

The FDA’s Center for Biologics Evaluation and Research (CBER) is launching a new program called INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs).  INTERACT meetings will replace pre-pre-IND meetings, but not formal product-specific meetings, such as pre-IND or pre-BLA meetings.

According to the announcement, sponsors will be able to obtain advice from FDA on a wide range of development-related topics.  INTERACT meetings can address topics like the requirements for preclinical testing of a product, aspects of manufacturing required for first–in–human trials, initial clinical development strategies, and device or assay design considerations.  These meetings could “streamline development by helping sponsors avoid unnecessary preclinical or other preparatory studies or plan initial clinical development strategies.”

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