FDA inspection backlog tops 1,000 — and could last for years — as House hearing raises serious concerns
A US House of Representatives subcommittee on Tuesday reignited bipartisan angst around the FDA’s drug manufacturing inspection backlog and attempts to improve its inspections process overseas.
The pandemic has forced the FDA to forgo more than 1,000 of its planned fiscal year 2020 inspections and the agency will likely face a backlog of future inspections for years to come, according to testimony from Mary Denigan-Macauley, director of health care at the Government Accountability Office (GAO).
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