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 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.
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