GCP Inspections: Corrective Measures For Adverse Findings Should Be Tested, US FDA Says

Sponsors, contract research organizations and study investigators on the receiving end of an FDA Form 483 following a bioresearch monitoring (BIMO) inspection should acknowledge the US agency’s observations, respond by explaining the corrective actions planned and how efficacy of those measures will be assessed.

These were some of the best practices described by representatives from the US Food and Drug Administration’s Center for Drug Evaluation and Research during a recent webinar