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US FDA Focuses On Harmonization With The Launch Of Generic Drug Cluster

As Agency Calls For Scientific And Regulatory Alignment Globally

Executive Summary

To improve common standards for global development for generics and access to generics, FDA has launched the Generic Drug Cluster through the Global Generic Drug Affairs team established by the FDA’s Office of Generic Drugs. The agency has listed objectives through which it aims to increase scientific alignment among leading generic drug regulatory agencies. 

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