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ORA busy training new investigators

This article was originally published in The Silver Sheet

Executive Summary

FDA's Office of Regulatory Affairs (ORA) is training an influx of new investigators and adjusting to the retirement of some of its most experienced staffers. According to Michael Chappell, acting associate commissioner for regulatory affairs in ORA, the office has hired more than 700 new device, drug and other investigators, and 70 analysts since 2008. This means about 30 percent of ORA's investigators are new, Chappell said at a recent Food and Drug Law Institute meeting in Washington, D.C. "This creates some major training and mentoring challenges," he said. Nevertheless, Chappell reiterated the new administration's commitment to stronger enforcement at FDA. The agency is already issuing warning letters much faster following an inspection, he said. In the first half of fiscal year 2010, FDA issued 378 warning letters, while it issued only 473 during the entire fiscal year 2009, Chappell noted

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