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# CBER Rolls Out INTERACT Meeting Option for Developers
- URL: https://www.fdaweb.com/cber-rolls-out-interact-meeting-option-for-developers/
- Published: 2018-06-25T12:00:00.000Z
- Updated: 2026-09-15T00:15:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141758

CBER has created a new dialog avenue for biologic product developers to ask agency experts for advice on advancing a potential product. The just-launched INTERACT meeting program may “help streamline development by, for example, helping sponsors to avoid unnecessary preclinical studies,” the [agency says](https://www.fda.gov/BiologicsBloodVaccines/ResourcesforYou/Industry/ucm611501.htm?ref=fdaweb.com). “At the same time, the INTERACT meeting is an opportunity for CBER to become familiar with novel products and technologies in development.”

The Center says that questions posed during INTERACT meetings should focus on the requirements for preclinical testing of a product, aspects of manufacturing required for first–in–human trials, initial clinical development strategies, device or assay design considerations, and similar topics. The meeting will replace the pre-pre-IND meeting process for all products across CBER. “However, INTERACT meetings do not replace formal product-specific meetings, such as pre-IND meetings or pre-BLA meetings, that take place later in development,” it says.

CBER plans to shortly post a revised Web page describing the INTERACT meeting program in greater detail.