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

03 Mar 2022

Sponsors, CROs and study investigators who receive an FDA Form 483 following a good clinical practice inspection should acknowledge the agency’s observations, explain the corrective actions planned, and how efficacy of those measures will be assessed, CDER officials say.

Derailed train — FDA wants to see processes in place to ensure that clinical trial operations don't go "off the rails" again. • Source: Alamy

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...

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

More from Clinical Trials

More from R&D