Joint development advice from the US Food and Drug Administration and European Medicines Agency on generic drugs has the potential to push both regulators to align their standards, and the potential for faster and cheaper drug approvals globally excites industry.
FDA-EMA Pilot Could Further Push Global Generic Harmonization, But Will Sponsors Use It?
Regulators hope parallel scientific advice pilot for complex generics is more popular than brand program was at start; sponsors want use of foreign comparator products and tighter harmonization.
