FDA Clinical Research Regulatory Actions

Latest Warning Letters

Medical Device Trials
Drug Trials
Biologics Trials
IRBs
Disqualification Notices
Disqualification Hearings

Many of the violations discussed in these cases could have been prevented. Federal regulations require clinical study "monitoring" but not "QA audits". More QA audits should find these problems and result in identifying CRAs who need additional training in how to fix the problems during their monitoring visits. QA Audits of monitoring visit reports should be done (as suggested by ICH) and on-site audits should be done, if warranted. FDA reviews monitoring reports but not QA audit reports.

You will see the comment "This violation was not included on the Form FDA 483" in some Warning Letters. What this means is that the FD-483 list of violations was incomplete and there may be more "gifts" in the Warning Letter.