CDER Conversations
CDER Conversation: OGD Global Affairs Program, One Year Progress Report of Generic Drug Cluster
CDER’s Office of Generic Drugs (OGD) ensures that Americans have access to safe, effective, and high-quality generic drugs. One of the ways OGD supports generic drug regulatory activities is through international engagements led by its Office of Global Operations’ Global Generic Drug Affairs Program.
Regulatory requirements and scientific approaches to developing and assessing generic drugs can vary from country to country, which can add complexity to the development and approval process for generic drug developers. OGD 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.
In this CDER Conversation, we reflect on the first-year progress of the Generic Drug Cluster with OGD’s Sarah Ibrahim PhD., associate director for Global Generic Drug Affairs.