Food & Drug Inspection Monitor

摘要

Human Drugs/Biologies: Kutol Products, Cincinnati, OH; Vi Jon Laboratories, St. Louis, MO; Medical Devices: Advanced Imaging Research, Cleveland, OH; Shelhigh, Union, NJ; Theken Spine LLC, Akron, OH; Inspection Log; FDA's new CMC review process aims to foster more efficient, science-based control of product quality: PHILADELPHIA — FDA's new systems-based approach to chemistry, manufacturing and control (CMC) review promises to be one in which companies that demonstrate adequate process knowledge and control will have less of a regulatory hammer hanging over their heads as they move through the NDA approval process.