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EUROPE – The General Court Limits the Scope of “Satisfactory Methods” That Must Be Compared for Orphan Drug Designation

On 23 September 2020, in a landmark case, Medac v Commission, the trial-level General Court (“GC”) of the European Union (“EU”) annulled the decision of the European Commission (“EU Commission”) that had withdrawn the orphan...more

EUROPE – Are Revisions of the Orphan Drug Regulation and Adoption of a Regulation on “Unmet Medical Needs” on the Horizon

The European Commission (Commission) has released a Staff Working Document concerning its joint evaluation of the Orphan Regulation and the Paediatric Regulation (collectively, the Regulations) (Joint Evaluation) and an...more

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