by SOCRA | Jun 14, 2021 | Clinical Research, clinical research regulations, Compliance, FDA
Mike M. Rashti President, BIMO Auditor and Trainer, LLC Abstract: This article provides an overview of the U.S. Food and Drug Administration’s (FDA’s) foreign inspection program and the Bioresearch Monitoring Program as it is applied to inspections in Canada. How to...
by SOCRA | Mar 29, 2020 | Clinical Research, clinical research regulations, FDA, FDA Drug Approval
U.S. Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA). As our society becomes more global, it has become increasingly clear that the U.S. Food and Drug Administration needs to take a more...
