Eisner Safety Consultants

FDA Speeds Process for Banning Bad Trial Investigators

RAPS (In The News) – The US Food and Drug Administration (FDA) has developed new procedures to help speed the process for barring noncompliant clinical trial investigators from future research. The new process will set specific timeframes and assign responsibility for each step to specific areas within the agency. The disqualification process will now be centralized in FDA’s Good Clinical Practices Office, whereas previously, responsibility resided in the center that initiated the disqualification action. Debarments will be centralized in the Office of Enforcement.