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
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focus of the draft is clearly on public requests arising out of Web 2.0 social media forums, the manner in which the draft guidance limits a firm's ability to substantively respond to public requests raises serious concerns in a both electronic and non-electronic media forums, including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.
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