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US-EU Mutual Reliance On Drug Facility Inspections Nears Reality

 
• By Sue Sutter

FDA expects to complete work this year on decision model to determine whether an EU member state's inspectorate is capable of conducting inspections that meet US requirements.

FDA may be able to start relying on European Union drug facility inspection findings from foreign regulators before the year is out.

Speaking at the Food and Drug Law Institute's Global Business Conference in Washington March 16, FDA Associate Commissioner for Global Regulatory Policy Dara Corrigan said the agency expects to complete work on a decision model this year that will enable it to determine whether an EU member state is capable of performing drug facility inspections to FDA's

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