UPDATE: RAPS Seeks Authors for EU Fundamentals Book; Deadline Extended
By RAPS Staff -
Published 30 March 2017
RAPS currently is seeking chapter authors for the upcoming eighth edition of Fundamentals of EU Regulatory Affairs.
Categories: HTML, Articles, Under RAPS, RAPS
Tags: EU regulatory affairs, EU, European Union, Europe
EU Court of Justice Denies EMA Appeal to Release Documents on Two Medicines
By Zachary Brennan -
Published 15 March 2017
The Court of Justice of the EU earlier this month delivered a blow to transparency efforts at the European Medicines Agency (EMA), dismissing two appeals by the regulator.
Categories: News, Europe, EMA, Clinical, Prescription drugs, Government affairs
Tags: PTC Therapeutics, Translarna, Court of Justice of the European Union
EU Court Rules on Orphan Product Exclusivity
By Michael Mezher -
Published 19 March 2015
A European Court has issued a ruling in an unlikely scenario dealing with overlapping periods of orphan product market exclusivity.
Categories: News, Europe, EC, EMA, Drugs, Orphan products, Regulatory strategy, Submission and registration
Tags: General Court of the Court of Justice of the European Union, CJEU, Orphan Product Designation, Market Exclusivity, Glivec, Tasigna, Teva