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
Industry Waits for Some Signal That FDA Will Rethink Its Proposed Approach to Unsolicited Requests
As previously reported, while a key focus of the draft is clearly on public requests arising out of Web 2.0 social media forums, the manner in which the draft guidance limits a firm's ability to substantively respond to public requests raises serious concerns in a both electronic and non-electronic media forums, including first amendment free speech concerns (See “FDA on Free Speech and How to Respond to Tweets” – MDDI: Medical Device & Diagnostic Industry, February 6, 2012). In light of the widespread concerns, it may be some time before stakeholders have an indication from FDA as to how the agency will proceed.
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