FDA caught up on domestic pre-approval inspections, foreign inspections still a challenge

RAPS

20 June 2022 - The US FDA eliminated its backlog of overdue domestic pre-approval inspections, yet such progress has been stunted at the international level as getting to sites in China has remained a challenge amid the country’s COVID-19 pandemic restrictions.

So asserted Patrizia Cavazzoni, the director of FDA’s Center for Drug Evaluation and Research, who provided an update on the center’s activities and priorities for 2022 at the Food and Drug Law Institute’s annual meeting last week.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation , Timelines