On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
Actelion Settles REMS Dispute with Generic Drug Manufacturers
This settlement follows an October 2013 decision in the case by U.S. District Judge Noel Hillman denying Actelion’s motion for judgment on the pleadings and allowing the case to proceed to discovery. However that ruling did not address the merits of the issues at the core of the lawsuit, and with this settlement it appears that these questions will remain unresolved for now.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017