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
Federal judge allows discovery to proceed in REMS duty to deal dispute
It is worth noting that despite the FTC's recent efforts to become involved in private antitrust suits involving the pharmaceutical industry (see here and here), it was unable to participate in the proceedings due to the recent government shutdown.
For additional background on the case and the issues, please refer to this article.
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