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
Is Inherent Reasonableness Coming Back to CMS?
CMS is contemplating the use of its authority to adjust payment amounts that are inherently unreasonable as an alternative to using the competitive bidding process for non-mail order testing supplies at this time. The agency believes that this will help reduce the difference in price between mail order and non-mail order diabetic testing supplies, and create program savings. In addition, it believes using its inherently unreasonable authority will allow beneficiaries greater choice of supplier than use of the competitive bidding process.
CMS will host a public meeting Monday, July 23, 2012 from 9 am to 1 pm to solicit comments from suppliers and other interested parties. Both oral and written comments will be accepted. Participants must register in advance.
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