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FDA approval rate up 7% in 2012, but still trails EU

This article was originally published in Scrip

Executive Summary

The US FDA upped its approval rate in fiscal 2012 to 76%, from 69% in 2011, the BioMedTracker 2012 FDA and EMA Approval Report from Sagient Research Systems’ BioMedTracker has found. It also approved a much higher proportion of new entities (rather than new indications for existing entities) than in previous years.






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