Rejection Rate Soars In Q4 For EU Fast-Track Requests
EMA Turned Down All But One Request In October And November
October and November 2020 were bad months for companies seeking to have their planned EU filings fast-tracked through the centralized drug review system at the European Medicines Agency.
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There is one orphan drug among the five new marketing authorization applications that the European Medicines Agency has under review. All five drugs will be reviewed under standard review timelines.
A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.
The latest drug development news and highlights from our US FDA Performance Tracker.