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FDA Focuses On Harmonization With The Launch Of Generic Drug Cluster

As Agency Calls For Scientific And Regulatory Alignment Globally

 
• By Akriti Seth

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. 

FDA
The FDA announces the launch of the Generic Drug Cluster • Source: FDA

The US Food and Drug Administration has announced the launch of the Generic Drug Cluster, “the first forum established to address generic drug development and increase scientific alignment among the world’s leading regulatory agencies.” The Generic Drug Cluster has been launched through the Global Generic Drug Affairs team established by the FDA’s Office of Generic Drugs. 

“Our opportunity for harmonization is now and movement toward common standards for global development for generics can improve access to...

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• By Dean Rudge

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More from Policy & Regulation

Viatris Targets Gilead’s Odefsey HIV Blockbuster In Europe With CHMP Recommendation

 
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• By Dave Wallace

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