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Good Clinical Practice Inspections Take On Narrower Focus During Pandemic, US FDA Says

 
• By Sue Sutter

Technological and logistical challenges have forced agency staff to triage document and interview requests to focus on the most important issues when conducting remote regulatory assessments and in-person inspections, an FDA official told a conference of international regulators.

Tunnel vision
FDA inspectors have narrowed the focus of good clinical practice assessments due to technological and logistical challenges resulting from the pandemic. • Source: Alamy

The two year-old COVID-19 pandemic has forced the US Food and Drug Administration’s bioresearch monitoring inspectors to narrow the focus of their good clinical practice evaluations and document requests – whether conducted remotely or on-site – due to technological and logistical challenges.

Remote regulatory requests may be a “heavy lift” for a clinical trial site involving multiple days of videoconferences with site...

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