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EMA Boosts Transparency On Maintaining Orphan Status At Time Of Approval

 
• By Vibha Sharma

New orphan maintenance assessment reports are expected to increase transparency around the European Medicines Agency's decision-making process on whether an orphan-designated drug continues to qualify as an orphan once it gets on to the market.

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The EMA Is Publishing More Info On Orphan Designations • Source: Shutterstock

The European Medicines Agency has started publishing its reasons for why drugs that were designated as orphan medicines during their development do or do not continue to fulfil the necessary criteria to be designated as orphans after they are recommended for approval by the agency.

The agency is publishing these decisions in the form of an orphan maintenance assessment report, the first of which was...

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