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
CMS Announces First “Qualified Entities” To Receive Medicare Data under Affordable Care Act Program
Given that CMS indicated that it would provide data under the QEP to every entity that met the regulatory criteria, the fact that it has identified only three quality entities suggests that the agency is strictly interpreting its own guidance. It also is worth noting that CMS had estimated in the final rule that 25 organizations would be approved to participate in the QEP as qualified entities. Although the application process is a rolling one, the fact that CMS has only approved three applications so far suggests that the program may not have a very significant effect on the dissemination of Medicare data.
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