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 Issues New Notice on Its National Coverage Determination Process
Perhaps the most novel aspect of the notice is a new "expedited administrative process" to remove certain NCDs, which would leave coverage determinations on the topic to the discretion of Medicare contractors. This process would impact NCDs that have not been reviewed for at least 10 years, and CMS would assess the continued need to have a national coverage policy on the topic. Under the process, CMS will publish a list of the NCDs it proposes to remove and accept public comments on the proposals before making a final decision.
This issuance by CMS is a notice that will be effective as of the date it is published in the Federal Register, which is expected to be August 7, 2013. CMS has not solicited comments on the provisions contained in the notice.
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