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FDAnews Drug Daily Bulletin
July 2, 2012 | Vol. 9 No. 129
The Devil You Don’t Know: FDA Issues Enforcement Action Based on Non-FDA Inspection
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.
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