FDA and European Medicines Agency launch generic drug application inspections initiative Mittwoch, 18. Dezember 2013 - 18:07

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.