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 Releases Final Rule on Essential Health Benefits
The final rule largely finalizes, with a few changes, the approach set forth in the proposed rule for EHB standards applicable in the individual and small group market. This approach gave states the flexibility to define EHB by selecting a benchmark plan from options offered in the market.
Appendix A of the final rule includes the final list of EHB-benchmark plans that will apply in years 2014 and 2015.
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