Dr. Jules Mitchel at NY Medical College, October 2014
Nobody wants to receive a Form FDA 483 after an FDA inspection of a clinical site, drug/device company, manufacturing plant or other entities subject to regulatory inspections. Nevertheless, while inspection findings are inevitable, they are not intended to be "the end of the world."
Target Health, Inc. participated in study design, regulatory activities, and data management, and reviewed all versions of the manuscript for this clinical trial.
Interaction is high on FDA’s list of ways to improve the development and review process for technologies.
Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs.
