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…
Tag: <span>potency</span>
Testing for parallelism is a fundamental requirement for assessing the validity of bioassay data used to calculate relative potency. When a test sample and the reference material are diluted and assayed, the assumption is that their dose response curves have an identical shape. The standard statistical approach to demonstrate that two curves are parallel involves testing the null hypothesis for equality. This article explains why that approach is not appropriate and presents an argument for testing the null hypothesis for a specified difference to statistically ascertain parallelism…