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
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.
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory...03 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