FDAnews Drug Daily Bulletin

FDA Issues Enforcement Action Based on Non-FDA Inspection

Aug. 20, 2012
International cooperation between regulators is “taking off” — a trend that could limit the amount of duplicate inspections drugmakers face, a top CDER official says. While “mutual recognition” of inspections is not yet a reality, drugmakers shouldn’t expect the FDA to close its eyes to negative inspection findings from other regulators. In one instance, the agency has even used another country’s inspection data to take regulatory action, Justina Molzon, CDER’s associate director for international programs, said at the Drug Information Association annual meeting.
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