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BioSlice Blog

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By: Arnold & Porter Kaye Scholer LLP

Blog Authors

Paul Abbott
Shama Aktar
Libby Amos-Stone
Daisy Bray
Alison Brown
Shishu Chen
Bonnie Clemence
Abbie Coombs
Mahnu Davar
Phillip DeFedele
Richard Dickinson
Ian Dodds-Smith
Emma Elliston
Niels Ersboll
Katya Farkas
Fenella Fletcher-Flood
Tom Fox
Zeno J. Frediani
Nadia Gracias
Kathy Harford
Keir Heinrich
Rhiannon Hughes
Hannah Kerr-Peterson
Katerina Kostaridi
Jackie Mulryne
Ludovica Pizzetti
Lewis Pope
Alexander Roussanov
Peter Saban
Dr Beatriz San Martin
Peter Schildkraut
John Schmidt
Eftychia Sideri
Christopher Stothers
Louise Strom
Louise Strom
Ewan Townsend
Elizabeth Trentacost
Lincoln Tsang
Silvia Valverde
Camille Vermosen
Zoe V. Walkinshaw
Laura Whiting
Ellecia Whiu
Jeremy Willcocks
Adela Williams
Eleri Williams
Sofia Wilson

Latest from BioSlice Blog

BioSlice Blog

UK PMCPA publishes long-awaited guidance on use of social media

By Adela Williams, Jackie Mulryne, Libby Amos-Stone & Katya Farkas
February 3, 2023

On 26 January 2023, the Prescription Medicines Code of Practice Authority (the PMCPA) published long-awaited Guidance on Social Media 2023 (the Guidance). While a Digital Guidance note, which covered certain issues arising from use of social media, was published…

BioSlice Blog

Parallel imports: identicality of products when repackaging

By Dr Beatriz San Martin, Jackie Mulryne, Shishu Chen & Shama Aktar
January 31, 2023

On 17 November 2022, the Court of Justice of the European Union (CJEU) delivered its preliminary ruling in joined cases C-253/20 Impexeco NV v Novartis (Impexeco), and C-254/20 PI Pharma v Novartis (PI Pharma), finding that where a parallel importer…

BioSlice Blog

Evaluation of New Active Substance Status for Biological Products in the EU

By Jackie Mulryne, Alexander Roussanov & Sofia Wilson
December 21, 2022

On 18 November 2022, the European Medicines Agency (EMA) published a draft reflection paper (Paper) for public consultation on the criteria for the evaluation of new active substance (NAS) status for biological substances. The Paper provides guidance for applicants on…

BioSlice Blog

Delay to EU MDR is on the horizon

By Jackie Mulryne, Eftychia Sideri & Eleri Williams
December 12, 2022

It is well known that there are significant problems with the implementation of the Medical Devices Regulation 2017/745 (MDR), in particular notified body capacity and the vast number of products that need to go through the new regime before the…

BioSlice Blog

The Retained EU Law (Revocation and Reform) Bill 2022 – key facts and issues

By Libby Amos-Stone, Dr Beatriz San Martin & Lewis Pope
December 8, 2022

Synopsis

On 22 September 2022, the UK government introduced the Retained EU Law (Revocation and Reform) Bill 2022 (the ‘Bill’) to Parliament. The Bill provides a mechanism to remove EU law currently on the national statute book and transition towards…

BioSlice Blog

Demystifying the UPC and the Unitary Patent – answers to some common questions

By Dr Beatriz San Martin, Shishu Chen & Shama Aktar
December 7, 2022

The Unified Patent Court (UPC) and the unitary patent system are expected to commence on 1 June 2023. Until early December 2022, the UPC was advocating 1 April 2023 as the date of entry into force of the Agreement on a Unified…

BioSlice Blog

Adoption of New Procurement Regulations in the UK

By Jackie Mulryne, John Schmidt & Sofia Wilson
December 1, 2022

The procurement landscape in the UK is due to change next year. A draft procurement bill (Bill) seeks to consolidate a number of different procurement regulations that originate from EU legislation, including the Public Contracts Regulations 2015 (PCR), into a…

BioSlice Blog

Virtual and Digital Health Digest

By Jackie Mulryne, Dr Beatriz San Martin & Emma Elliston
November 21, 2022

Welcome to the first installment of Arnold & Porter’s Virtual and Digital Health Digest. This inaugural edition covers September and October highlights across the virtual and digital health space. This newsletter focuses on key virtual and digital health and…

BioSlice Blog

Latest on software and AI devices from the MHRA

By Jackie Mulryne & Eleri Williams
October 27, 2022

The MHRA is continuing to publish details on how software and AI medical devices will be regulated in the UK post Brexit, with the aim of making the UK an attractive place to launch such products. The MHRA’s recent updates…

BioSlice Blog

ATTENTION SOCIAL MEDIA USERS: New IFPMA and EFPIA Guidance on use of social media by industry

By Jackie Mulryne & Libby Amos-Stone
September 29, 2022

The international and European self-regulatory bodies for the research-based pharmaceutical industry (IFPMA, International Federation of Pharmaceutical Manufacturers and Associations and EFPIA, European Federation of Pharmaceutical Industries and Associations) yesterday published a Note for Guidance to assist member…

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