Cellular and Gene Therapies Interactive Site Tours Program for Regulatory Project Managers and Reviewers; Information Available to Industry
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Issuing agencies
Abstract
The Food and Drug Administration's (FDA or the Agency) Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) is announcing the Cellular and Gene Therapies Interactive Site Tours Program (the Interactive Site Tours Program). This program is intended to give CBER regulatory project managers and/or reviewers an opportunity to tour biotechnology manufacturing facilities developing cellular and gene therapy products, and to exchange regulatory experiences with their industry counterparts. With this program, CBER intends to enhance review efficiency and quality by providing CBER staff with a better understanding of the biotechnology manufacturing industry and its operations. The purpose of this notice is to invite companies developing cellular and gene therapy products interested in participating in this program to contact OTP for more information.
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