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(Initial Targeted Engagement for Regulatory Advice on CBER Products)

INitial Targeted Engagement for Regulatory Advice on CBER producTs (INTERACT) meeting is an informal non-binding consultation with the Center for Biologics Evaluation and Research (CBER) at FDA. An INTERACT meeting enables sponsors to obtain preliminary informal consultation for innovative investigational products at an early stage of development on issues that are not yet at the pre-IND meeting phase.

The INTERACT program generally consists of one informal and non-binding consultation and is intended for innovative investigational products that introduce unique challenges due to the unknown safety profiles resulting from the use of complex manufacturing technologies, development of innovative devices, or cutting-edge testing methodologies. Before requesting an INTERACT meeting, a sponsor needs to have selected a specific investigational product or a product-derivation strategy to evaluate in a clinical study.

For details and procedures for requesting an INTERACT meeting, please see CBER’s SOPP 8214: INTERACT Meetings with Sponsors for Drugs and Biological Products.

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