by Darin J. Weber, PhD, Stephanie Simek, PhD, and Raj K. Puri, MD, PhD
Volume 2, Issue 4 (July/August 2003)
On January 31, 2003, FDA under the leadership of Commissioner Dr. Mark McClellan, issued a report entitled “Improving Innovation in Medical Technology: Beyond 2002.” One of the goals described in this report is to “speed potentially important emerging technologies to the market by reducing regulatory uncertainty and increasing the predictability of product development.” The technology areas of cell therapy and gene therapy were specifically identified. This article highlights some of the challenges for manufacturers and regulators of these products and describes ongoing efforts at FDA — as well as opportunities to partner with FDA — to improve the product development process for cell therapy and gene therapy products…
Citation:
Weber DJ, Simek S, Puri RK. FDA Educational Partnerships to Improve the Development of Cell and Gene Therapy Products. BioProcess J, 2003; 2(4): 23-25.