Members of the European Parliament (MEPs) have voted overwhelmingly in favour of the pharmaceutical reform package following a debate on 10 April.
The vote is a key step in the passage of the new Directive and Regulation, which together form
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Members of the European Parliament (MEPs) have voted overwhelmingly in favour of the pharmaceutical reform package following a debate on 10 April.
The vote is a key step in the passage of the new Directive and Regulation, which together form…
On 20 March, the Commission proposed several measures intending to boost technology and biomanufacturing in the EU, including the Commission Communication Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU; and Questions & Answers on the Commission…
This digest covers key virtual and digital health regulatory and public policy developments during February 2024.
Of note, the UK continues to pursue a “pro innovation” flexible approach to the regulation of AI. As outlined in the UK government’s response…
On 15 March 2024, the European Parliament and the Council of the European Union (EU legislators) reached a provisional agreement on the text of the Regulation creating a European Health Data Space (EHDS).
Please note that the text of the…
This digest covers key virtual and digital health regulatory and public policy developments during January 2024.…
A version of this article was first published in Life Sciences IP Review
There is currently no specific legislation in the UK that governs AI, or its use in healthcare. Instead, a number of general-purpose laws apply that have to…
On 1 February 2024, the Danish Data Protection Agency announced that it reported the private hospital HP Gildhøj Privathospital ApS’s (Capio A/S) to the Danish police and recommended imposing a fine of not less than DKK 1,500,000 (over 200.000 euros).…
On 2 February 2024, the US Food and Drug Administration (FDA) published its much anticipated final rule amending the medical device Quality System Regulation, which sets out the FDA’s quality management system (QMS) requirements for medical devices. The amendments seek…
On 23 January 2024, the European Commission announced proposals to amend the Medical Device Regulations (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulations (EU) 2017/746 (IVDR), as applicable, to:
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