US FDA Focuses On Harmonization With The Launch Of Generic Drug Cluster
As Agency Calls For Scientific And Regulatory Alignment Globally
Executive Summary
To improve common standards for global development for generics and access to generics, FDA has launched the Generic Drug Cluster through the Global Generic Drug Affairs team established by the FDA’s Office of Generic Drugs. The agency has listed objectives through which it aims to increase scientific alignment among leading generic drug regulatory agencies.
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Global development path proposed to ICH by FDA
Aset of “internationally harmonised guidelines on scientific and technical standards for generic drugs” should be developed through the International Council forHarmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), according to a proposal that has been put forward by the US Food and Drug Administration (FDA).