STEM CELL FACTOR REGULATION AS MEDICAL DEVICES COULD EASE PREMARKET RULES, FDAer SUGGESTS; PHS XENOTRANSPLANTATION GUIDELINES EXPECTED "IMMINENTLY"
This article was originally published in The Gray Sheet
Executive Summary
FDA regulation of stem cell growth factors could be eased by classifying the products as medical devices, Philip Noguchi, director of the Division of Cellular and Gene Therapy in FDA's Center for Biologics Evaluation and Research, said at an International Business Communication meeting in San Francisco Jan. 18.