Clinical Investigator Receives Warning Letter Over Subject Dosing
September 5, 2024 at 03:18 PM EST
A clinical investigator in Atlanta received an Aug. 20 Warning Letter for allegedly failing to ensure a clinical trial was conducted according to the investigational plan (21 C.F.R. §312.60).
The Warning Letter to Dr. Julio Flamini with the Research Center of Atlanta was the result of a Feb. 28-March 11 inspection conducted as a part of the FDA’s Bioresearch Monitoring Progra... Read More
