Generic Drug Cluster Initiated by FDA to Improve Global Regulatory Alignment

The FDA has launched the Generic Drug Cluster, calling it the first forum of its kind focused on increasing scientific alignment among regulatory agencies in countries that focus on generic drug development.

A key goal of the new forum is to achieve a common understanding of each agency’s regulatory requirements for approval and current thinking on topics related to generic drug development, the agency said in a tweet from its FDA Drug Information Twitter account.

The new forum will also offer a confidential platform for discussion of policies in development, including draft guidances for industry, and the scientific basis for decisions on those policies, the agency said.