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One Year On, US FDA Generic Drug Cluster Focuses On Facilitating Collaboration

Group Has Made Significant Progress Regarding Data Sharing

 
• By Chloe Kent

Following its inaugural year, the FDA’s Generic Drug Cluster has formed data sharing arrangements concerning a number of vital indications.

Wooden figures of people gathered around green globe
Several initiatives in the off-patent industry are now focused on regulatory harmonization • Source: Shutterstock

The US Food and Drug Administration’s Generic Drug Cluster has facilitated the gathering and combining of data in several key indications during its first year in operation, a progress report has revealed.

The group said the discussions it has had over the last year “promoted an understanding of approval basis focusing on...

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