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Fewer Warning Letters: Does Change Point To FDA Advancement Or Decline?

This article was originally published in The Tan Sheet

Executive Summary

A growing preference for voluntary compliance from drug firms is one contributor to the "steady decrease in the number of CDER warning letters," according to FDAer Robert Maffei

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Industry Input Will Bolster Risk-Based Inspection Approach – FDA’s Ellsworth

FDA is "hoping" to use future facility inspections to compile data that will strengthen the "process risk" prong of its risk-based site selection model by gaining knowledge about quality systems currently in use by industry, according to New Jersey District Director Douglas Ellsworth

FDA enforcement declines – House report

FDA enforcement of food and drug laws declined "dramatically" between 2000 and 2005, and FDA officials "routinely reject the enforcement recommendations of career field staff," according to a report released by the Democratic staff of the House Government Reform Committee June 26. The report was requested by Rep. Henry Waxman (D-Calif.). The number of warning letters sent by the agency for violations decreased in all FDA centers by an average of over 50%, from 1,154 issued in 2000 to 535 in 2005, the report states. Warning letters for the Center for Food Safety & Applied Nutrition declined 45%. Additionally, the number of products seized by the agency for being defective, mislabeled or dangerous dropped 44%, the study finds. The decrease in enforcement actions does not indicate a reduction in violations; the number of violations reported by FDA field agents has remained relatively constant, the report maintains. Waxman, CSPI and Public Citizen held a joint news conference on FDA's "failings" June 27....

GMP Warning Letters: FDA Approves 55% Of Field Recommendations

FDA's central review of good manufacturing practices warning letters has been effective in creating consistency in the communications, the agency says

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