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In March 2020, because of COVID-19 health risks and travel
restrictions, the Food and Drug Administration (FDA) suspended most
of its inspection program, both in the United States and abroad.
The agency limited inspections to those that were priority or
mission critical, including some pre-approval inspections for
important new therapies and some for-cause inspections. During the
pandemic, FDA also increased its use of some alternatives to
in-person inspections, such as relying on inspections by foreign
regulators and requesting records in lieu of inspection.
1 To
this point, FDA had not embraced real-time video assessments, in