Drug Development Pharma - January 9, 2014
FDA and European Medicines Agency launch generic drug application inspections initiative
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have 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. Studies […]
