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EMA Says No To Extending Clock-Stops For Immature Marketing Applications

Companies Should Ensure Dossiers Are As Mature As Possible From Day One

 
• By Vibha Sharma

The European Medicines Agency wants to discourage drug companies from submitting marketing applications with very interim data cuts and then expecting they can supplement their application with more data later on by requesting for extended clock-stops.

Close up Businessman in Black Suit Showing Time Out Sign, Isolated on Gray Background.
Companies Are Increasingly Asking For More Time To Respond To EMA’s Questions (Shutterstock)
Key Takeaways
  • The European Medicines Agency is clamping down on delays to its evaluation process caused by companies asking for extended clock-stops.

The European Medicines Agency says it has seen an increasing trend among companies submitting interim data in their drug marketing...

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