AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Episode 132: Dr. Ehsan Jabbarzadeh, Co-Founder, Obsidio, and Professor, USC
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
Healthcare Headlines: Episode 8 – Healthcare Lending Deal Landscape Trends and Forecasts for the Future
Healthcare Headlines: Episode 7 — Evolving Landscape of Healthcare Provider & Medical Product Liability
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
On 21 May 2024, the European Medicines Agency (“EMA”) published a revised version of the Questions & Answers for applicants, Marketing Authorisation Holders of medicinal products and notified bodies with respect to the...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more
In Short - The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more
In this Q3/23 issue of our Life Science and Health Care Law Update, our teams highlight key trends across life sciences regulatory, corporate, compliance, competition, and privacy throughout the EU. We highlight the following...more
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more
Hosted by C5 Group, the 21st Annual Life Sciences IP Summit returns for another exciting year with curated programming with speakers from the pharma, biotech and medical device industries that will provide practical insights...more
The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation for the Great Britain market and an...more
The European Union (EU) has just published its proposals to revise its general pharmaceutical legislation. One of the objectives of the revision is to reduce the regulatory burden on the pharmaceutical industry when seeking...more
Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more
This regular update (no. 98 | 1 March 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more
On March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when Regulation (EU) 2023/607 (the “Regulation”) was published in the Official Journal of the European Union. The...more
The eleventh edition of The Life Sciences Law Review covers a total of 24 jurisdictions, providing an overview of legal requirements of interest to pharmaceutical, biotechnology and medical device companies. The chapters are...more
The EU is currently overhauling its product liability laws. Prompted by the perceived risks of new technologies and a desire to make it easier for claimants to bring claims for medical device and pharmaceutical claims, the...more
This regular update (no. 95 | 9 January 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more
As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more
This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion....more
With a goal of ensuring medicinal supply interruptions are better managed, the Dutch Ministry’s Policy Rule regarding ‘iron stock’ sets obligations for marketing authorisation holders and wholesalers to keep a minimum safety...more
COMPETITION & STATE AID - State Aid - European Commission approves new and amended Member State measures to support the economy - Since the onset of the coronavirus outbreak, the Commission has adopted a significant number...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to its consultation on the future regulation of medical devices in the United Kingdom which ran between September and November...more
RUSSIA RESPONDS TO WESTERN SANCTIONS WITH PATENT RETALIATION - On March 6, 2022, the Russian government retaliated against the West’s imposition of sanctions by issuing a decree permitting patented innovations to be used...more
COMPETITION & STATE AID - State Aid - European Commission adopts Temporary Crisis Framework to support economy in context of Russia's invasion of Ukraine - On 23 March 2022, the Commission adopted a Communication on a...more