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It’s Started: EMA Proactively Publishes Clinical Data On New Drugs

 
• By Vibha Sharma

The European Medicines Agency has delivered on its promise to grant public access to clinical reports that form the basis of its recommendations to the European Commission on whether or not a medicine should be authorized for use in the EU.

The European Medicines Agency has started publishing for public access the clinical reports that drug companies submit to support their marketing authorization applications, marking the official launch of its landmark policy on proactive publication of clinical trial data.

The EMA said on Oct. 20 that it had already published on its new, publicly-accessible website over 100 clinical reports for: Amgen's Kyprolis (carfilzomib), an orphan drug for treating multiple...

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