When the Food and Drug Administration (FDA) identifies significant findings with the conduct of a clinical trial during an inspection, what happens to those findings? According to a article published online by JAMA Internal Medicine, those findings remain hidden in plain sight.
Charles Seife, MS, a professor at the Arthur L. Carter Institute of Journalism at New York University, conducted a research study that sought to “identify published clinical trials in which an FDA inspection found significant evidence of objectionable conditions or practices, to describe violations, and to determine whether the violations are mentioned in the peer-reviewed literature.”
Topics: Charles Selfe, FDA Warning Letters, FDA Inspection