Keep Us In The Loop: EMA Clarifies Expectations Following PRIME Kick-Off Meetings
New guidance from the European Medicines Agency explains how sponsors that have drugs in its priority medicines scheme should interact with its experts and committees.
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With just three marketing applications filed, the European Medicines Agency says it is too soon to say whether PRIME, its priority medicines scheme, is meeting its objective. The agency is satisfied, though, that the scheme has started to drive innovation.
Advice on the acceptability of registry-based studies as a source of evidence for regulatory purposes is included in new guidance from the European Medicines Agency.
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