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Tag Archives: medicinal products EU clinical data

The EMA publishes a reflection paper on the use of extrapolation in the development of medicinal products for paediatrics

The reflection paper and extrapolation The European Medicines Agency (EMA) has published a reflection paper regarding the use of extrapolation when developing medicinal products for paediatric use. The main focus of the reflection paper is to provide a framework and guidance for the use of extrapolation in the development of medicinal products in paediatric patients.

THE COURT OF JUSTICE OF THE EUROPEAN UNION ORDERS THE REVIEW OF AN INJUNCTION BLOCKING THE RELEASE OF CLINICAL STUDY DATA BY THE EUROPEAN MEDICINES AGENCY

On 28 November 2013, the Court of Justice of the European Union (“CJEU”) set aside the order of the General Court of the European Union (“General Court”) in the Case T‑44/13 R AbbVie v EMA, wherein AbbVie successfully sought the suspension of the operation of a decision by the European Medicines Agency (“EMA”) to grant