The FDA’s Global Generic Drug Affairs program has launched the Generic Drug Cluster, the first forum established for the world’s leading regulatory agencies to address generic drug development globally. The Generic Drug Cluster aims to increase scientific alignment among leading generic drug regulatory agencies by fulfilling the following objectives:
• Achieving a common understanding of each Agency’s regulatory requirements for approval and current thinking on topics related to generic drug development through information sharing on approval requirements and recommendations conveyed in guidance documents.
• Offering a confidential forum for exchange of discussion on policies in development, including draft guidances for industry, and the scientific basis for decisions on those policies.
• Provision of a forum for a discussion of general and product/class-related scientific review issues and fostering alignment in approaches to scientific evaluation whenever possible.
• Addressing long-term safety issues to ensure a global safety net for generic drugs through confidential sharing of reports.
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