Clinical trial sponsor failed to get FDA approval
July 10th, 2008 joshua
A sponsor-investigator failed to get Food and Drug Administration approval for an experimental prosthesis and has been warned by regulators about his practices.
The FDA says Charles Hamlin enrolled 47 people in a trial of a prosthesis. He was supposed to get an investigational device exemption before commencing the trial, but failed to do so.
Patients participating in the trial were supposed to fill out proper forms at the time of their first visit, but the FDA says some of these incomplete forms were filled out nearly a year following the treatment.
In a warning letter from the FDA, Hamlin is cited with failure to prepare and submit accurate and timely reports of adverse side effects or injuries.
Hamlin provided no patient information for several of his patients.
