News about GMP/cGMP


FDA presents first global forum for generics

FDA presents first global forum for generics

In early June, the FDA unveiled the Generic Drug Cluster, the first forum for leading regulatory authorities to address the global development of generic drugs.

The focus here is primarily on optimizing scientific coordination between the authorities. The goal, FDA said, is to establish a common understanding of the regulatory requirements for generic drugs. In addition, the forum is a platform where confidential review issues and assessments can be discussed and aligned. There is an opportunity to share safety reports with each other and discuss safety issues in order to build "a global safety net for generic drugs".


FDA: Newsroom