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

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

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