Supply Chain Council of European Union | Scceu.org
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Government watchdog blasts FDA for poor oversight of drug supply chain

WASHINGTON — A government watchdog blasted the Food and Drug Administration for fumbling its oversight of the safety of the U.S. drug supply chain, suggesting the agency is not adequately conducting drug safety inspections overseas.

The criticisms came in a Tuesday hearing before the Senate Finance Committee, at which a top official for the Government Accountability Office outlined a number of surprising deficiencies in the FDA’s surveillance of foreign drug manufacturing. It highlighted, in particular, the agency’s longstanding practice of alerting drug makers in advance that it plans to conduct an inspection. U.S.-based drug makers do not get a similar heads up.

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