Search Results for European Union

Showing 1 – 3

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