by SOCRA | Apr 15, 2020 | Clinical Research, Investigational Drugs and Devices (IDE/IND)
Tim Reeves, CHFP Founder and Managing Director Human Factors MD Abstract: Human factors simulated-use studies provide a valuable tool for evaluating the usability and safety of medical devices, including combination products such as inhalers, injection devices, and...
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...
