FDA and European Medicines Agency launch generic drug application inspections initiative

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA and European Medicines Agency launch generic drug application inspections initiative

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FDA and European Medicines Agency launch generic drug application inspections initiative

12/18/2013 09:16 AM EST

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies.

 

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