How it feels with the tables turned
This article was originally published in The Gold Sheet
An FDA working group is meeting weekly to prepare for a second-round audit by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), an international organization of pharmaceutical inspection agencies that is considering FDA's membership application, FDA's Brian Hasselbalch told the FDA/Xavier University Global Outsourcing Conference last month in Cincinnati. As with congressional oversight, "Having the tables turned on you is not pleasant," he said, but "I think we're a better agency for it." One issue is FDA's continuing inability to mandate recalls, something Congress is working to address
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