The FDA recently revamped its debarment and disqualification procedures to better prevent non-compliant investigators and others from participating in new product development.
The government agency currently has the authority to ban individuals from working for companies with approved or pending drug applications at the FDA, and can also disqualify researchers conducting clinical testing of new drugs and devices for unethical or illegal practices.
To improve its processes, the FDA increased staffing and centralized coordination. In addition, the FDA has made available all pending and completed disqualification proceedings on its Web site.
In the short time these measures have been in effect, the number of debarment actions has increased and the times for resolving both disqualification and debarment actions have been reduced significantly.
