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Drug industry pushes FDA to solve growing inspection backlog


POLITICO
Drug industry pushes FDA to solve growing inspection backlog
Inspections are a vital tool to ensure the safety of new drugs as well as medicines already on the market.
Food And Drug Administration inspectors have been unable to travel as extensively as they need to. | Sarah Silbiger/Getty Images
By SUZANNE SMALLEY
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The Food and Drug Administration is under increasing pressure from the pharmaceutical industry to address the growing backlog of drug inspections nearly a year after Covid-19 prompted the agency to halt most plant visits.
From March through September, FDA inspected just three plants outside the U.S., well below the 600-plus it visited in each of the prior two years, the Government Accountability Office said last month. FDA has also struggled to keep up with inspections within U.S. borders, conducting just 52 during the same seven-month period last year, compared with roughly 400 each in 2019 and 2018. ....

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