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
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.
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