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Results:1-10 of 2,506

MedTech Europe requests extension to the transition period for the MDR
  • Arnold & Porter Kaye Scholer LLP
  • United Kingdom, European Union
  • August 2 2018

Last week, MedTech Europe, the European trade association representing the medical technology industries, published a position paper calling on the


Update to ABHI Code of Practice
  • Arnold & Porter Kaye Scholer LLP
  • United Kingdom
  • July 31 2018

The Association of British HealthTech Industries (ABHI) has this week published an update to their Code of Ethical Business Practice for the recently


CJEU rules on SPCs for combination products
  • Arnold & Porter Kaye Scholer LLP
  • European Union
  • July 25 2018

On the morning of 25 July 2018, the Court of Justice of the European Union (the CJEU) handed down judgment in Case C-12117 Teva UK and Others v


Update on the EMA’s Policy on Publication of Clinical Data
  • Arnold & Porter Kaye Scholer LLP
  • United Kingdom, European Union
  • July 19 2018

In a report published on 16 July regarding the implementation of its flagship policy on the publication of clinical data (Policy 0070), the EMA has


UK Government’s Brexit White Paper
  • Arnold & Porter Kaye Scholer LLP
  • United Kingdom
  • July 13 2018

Yesterday, the UK Government finally published its White Paper setting out its position on the UK’s continued relationship with the EU post-Brexit


EMA publishes results of study on Brexit preparedness
  • Arnold & Porter Kaye Scholer LLP
  • United Kingdom, European Union
  • July 13 2018

In January 2018, the European Medicines Agency (the EMA), as part of its Brexit preparations, launched a survey to gather information from companies


Update to the EMA’s Position on Access to Documents
  • Arnold & Porter Kaye Scholer LLP
  • European Union
  • June 29 2018

On 27 June 2018, the EMA published a short notification on its website informing readers that “The Agency is no longer in a position to process access


Clinical trial consents under the EU GDPR: where do we stand?
  • Arnold & Porter Kaye Scholer LLP
  • United Kingdom, European Union
  • June 28 2018

The General Data Protection Regulation (GDPR) entered into force on 25 May 2018 and, in the absence of any transition period, companies are now


Launch of the EMA’s Orphan Designation Portal
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • June 20 2018

Yesterday, the EMA launched a new secure online portal called IRIS for the submission of applications for orphan designation and the management of


Update on the EU Clinical Trials Portal and Database
  • Arnold & Porter Kaye Scholer LLP
  • European Union
  • June 15 2018

While the Clinical Trials Regulation (EU No. 5362014) (the Regulation) was adopted in April 2014, the Regulation does not come into operation until 6