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
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.
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