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
Preliminary Code Decisions Issued by CMS
Code applicants may submit materials responding to the preliminary decision and indicate their desire to make a presentation at the public meeting, but must do so by April 24, 2012. Additional preliminary code decisions for other types of products are expected to be issued by CMS in the next few days, so stay tuned!
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