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

Group Has Made Significant Progress Regarding Data Sharing

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 a number of generic drug applications of high priority, as well as

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