AUTOLOGOUS CELL PRODUCT QUALITY ASSURANCE PROCEDURES CAN BE FLEXIBLE, FDA SAYS IN GUIDANCE; DOCUMENT ACKNOWLEDGES UNIQUE NATURE OF SOME MAS PRODUCTS
This article was originally published in The Gray Sheet
Executive Summary
Autologous cell product manufacturers may use flexible acceptance criteria and specifications in certain quality assurance procedures in order to accommodate the unique nature of some cell therapy products, FDA says in a new guidance document on premarket requirements for autologous somatic cell therapy products.