The Retained EU Law Bill is now an Act of Parliament, having received Royal Assent on 29 June 2023. In our blog, published at the end of last year, we explained the draft Bill’s key features. Since then,
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European Parliament Adopts Its Version of AI Act
On June 14, 2023, an overwhelming majority of the European Parliament (Parliament) recently voted to pass the Artificial Intelligence Act (AI Act), marking another major step toward the legislation becoming law. As we previously reported, the AI Act regulates…
New UK International Recognition Routes for Medicines
On 26 May 2023, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced plans to introduce new international recognition routes for medicines, whereby the MHRA can recognise decisions to authorise medicinal products taken in other countries so the MHRA…
Demystifying the UPC and the Unitary Patent
Answers to Some Common Questions
After many years of debate, negotiations and work, the Unified Patent Court (UPC) and the unitary patent system were finally launched on 1 June 2023. In this publication, we demystify confusing terminology and misconceptions by…
BGMA refused permission for judicial review in relation to negotiation of the voluntary scheme
In a judgment handed down today, 10 July 2023, Mr Justice Turner refused permission for an application by the British Generic Manufacturers Association (BGMA) for judicial review of the refusal of the Secretary of State for Health and Social Care…
Latest Virtual and Digital Health Digest
We have finalised the latest installment of our Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during May 2023 from the United States, United Kingdom, and European Union.
For…
UK Medical Devices Update: Implementation of the UK Medical Devices Regulations and new Innovative Devices Access Pathway
Post-Brexit, the MHRA has been consulting on the future medical devices regulations, and how to retain the UK’s position as an attractive place to launch devices. As part of this, there have been a number of recent announcements about the…
Proposed Amendments to the EU Regulatory Framework for Medicinal Products
Join Me and a Panel of Experts Tomorrow for “Traps for Appellate Out-of-Towners: Differences Among Neighboring State Appellate Practices (West Coast Edition)”
Tomorrow at 3:00 pm Eastern (noon California time), I will join a panel discussion of the principal differences between state appellate practices around the country. The first in a series, this time we will be discussing Arizona, California and Nevada.…
Extension to EU MDR transition periods finalised
With much fanfare, in January 2023, the European Commission released its proposal to extend the MDR transition periods and abolish the ‘sell-off’ deadline, after which medical devices and in vitro diagnostics (IVDs) would have to be withdrawn from the EU…