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Harmonization and Global Efforts for Safe and Effective Generic Drugs

21 March 2023

Generic drugs play an important role in helping to address rising health care costs and in promoting access to medicines. Development and availability of generic drugs is a challenge in the United States and globally. In addition, the requirements and scientific approaches to developing and assessing generic drugs can vary from country to country. To help address all of these issues, FDA established a multi-country forum, the Generic Drug Cluster, to achieve a common understanding of each member agency’s generic drug regulatory requirements and to help increase scientific alignment.

- Mathew Cherian PhD Consultant Self employed - The United States

- Sarah Ibrahim, Associate Director CDER, US FDA - The United States