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US Reliance On EU Drug Facility Inspections Begins In November

 
• By Sue Sutter

FDA will have completed capability assessments for eight European Union member country inspectorates by that time, with all 28 to be completed by mid-2019; EU assessment of US regulator’s inspection capabilities wraps up in July.

The US FDA will start recognizing drug manufacturing facility inspections conducted by certain European Union member states in November under the US/EU mutual recognition agreement.

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