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
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.
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders...03 January 2017