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
HHS Releases Guidance on Federally Facilitated Exchanges and a Draft Blueprint for Approval of Exchanges
- How states can partner with HHS to implement selected functions in an FFE (aka “State Partnership Model”);
- Key policies organized by exchange function; and
- How HHS will consult with a variety of stakeholders to implement an FFE.
The agency is accepting comments regarding this guidance through June 18, 2012. Comments should be sent to FFEcomments@cms.hhs.gov.
Also on May 16, 2012, CCIIO released a draft blueprint for approval of a state-based or partnership exchange on May 16, 2012. According to this guidance, HHS will approve states wishing to operate either State-Based or Partnership Model Exchanges based on the state’s submission of a Blueprint, which must include both of the following components: (1) a Declaration Letter; and (2) an Exchange Application. The required elements of this letter and application are spelled out in further detail in the guidance. For plan year 2014, the complete Blueprint must be submitted by November 16, 2012.
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
The Scottish government has announced plans to implement the 28 recommendations proposed in an independent review of access to new end-of-life, orphan and ultra-orphan medicines by patients ...23 December 2016