Agency begins 'swift' enforcement actions

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Less than three weeks after FDA commissioner Margaret Hamburg pledged better enforcement against firms violating agency laws and regulations, swifter and more aggressive actions by the agency are already being felt as the agency dismantles a controversial Bush administration directive that required all FDA Warning Letters to be screened by the Office of Chief Counsel (OCC).

FDA presenters at a University of Rhode Island College of Pharmacy “GMP by the Sea” conference appeared to be energized by the new enforcement posture. One industry questioner welcomed the end of OCC Warning Letter reviews, but he was also concerned that as a result “we may have a lack of consistency and uniformity in what Warning Letters are issued for by districts around the country.

FDA's Division of Field Investigations director Mike Rogers noted that all domestic Warning Letters will continue to have product center review and concurrence for consistency purposes.

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