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 Moves Forward with National Average Drug Acquisition Cost (NADAC) Survey and Publication
CMS first proposed the creation of NADACs last summer. Stakeholders submitted comments regarding that proposal and the current implementation plan, detailed in a “Draft Methodology” document included on the CMS website, responds to that stakeholder input. CMS appears poised to implement the NADAC survey immediately, with survey requests going out to pharmacies as early as today, June 1. Surveys are due within 14 days, which puts CMS in the position to potentially release its first NADAC file at the end of June, for states to use effective July.
Publication of NADACs would represent a significant move toward price transparency in the retail pharmacy marketplace. The public availability of these prices means that private payers and manufacturers also will gain insight into current retail prices, and potentially use those data for their own commercial purposes as well.
CMS is accepting comments on its Draft Methodology until June 21, 2012, at RPS@cms.hhs.gov.
Further detail is available through a Hogan Lovells Health Alert published on June 4, 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