EU Accelerated Assessment – Hard To Get, Hard To Keep
It’s hard enough in the first place for companies to persuade the European Medicines Agency that their planned marketing authorization application should be fast-tracked. Many are also finding that after accelerated assessment is granted, it is taken away during the actual review.
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Leniolisib has become the first product to be granted accelerated assessment status by the European Medicines Agency this year.
If Zolgensma gets the thumbs up from the EMA this week, it will likely get formal EU approval within a couple of months.
The EU marketing application for cefiderocol that lost fast track status last July is now up for an opinion by the European Medicines Agency.