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OTP Interact Meeting for CBER-Regulated Products

INTERACT or an INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs is a meeting at a specific time early in product development. The appropriate timing for an INTERACT is when a sponsor has identified the investigational product to be evaluated in a clinical study and conducted some preliminary preclinical proof-of-concept studies with the intended investigational product, but has not yet designed and conducted definitive toxicology studies.Considerations for whether the status of product development is premature or too advanced for an INTERACT meeting are discussed later in this webpage. For additional details on a development program’s qualification for INTERACT, how to request and where to send the meeting request, please see SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products. Additionally, sponsors may now email meeting requests to cberdcc_emailsub@fda.hhs.gov.

*Note: If you are submitting a meeting request for a CDER-regulated product, contact druginfo@fda.hhs.gov for instructions on how to submit it to CDER.


Resources for INTERACT Meetings

SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products found at https://www.fda.gov/media/84040/download

 
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