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
With COVID diagnoses spiking across the United States this summer, we cannot yet claim that the pandemic is behind us. In fact, we are still experiencing residual medical device and equipment shortages, which has caused...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
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
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
COMPETITION & STATE AID - Competition - Commission publishes Competition Policy – 2021 at a glance. On 22 December 2021, the European Commission published its Competition Policy – 2021 at a glance. ...more
In addition to its significant efforts to fast track the approval of COVID-19 related devices, the FDA’s Center for Devices and Radiological Health (CDRH) has also maintained its high priority focus on supporting innovation...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: Woodcock...more
COMPETITION & STATE AID - Competition - Executive Vice President and Competition Commissioner Margrethe Vestager speaks at U.S. Chamber of Commerce's Transatlantic Business Works Summit. ...more
In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more
COMPETITION & STATE AID - State Aid - European Commission adopts revised Guidelines on State aid to promote risk finance investments- On 6 December 2021, the Commission published its Communication on Guidelines on...more
COMPETITION & STATE AID - European Commission comments on transatlantic relations in post-pandemic world, including building resilient supply chains - On 12 November 2021, Executive Vice-President and Competition...more
According to an article published in Nature Biotechnology, Harvard and MIT researchers invented a face mask for detecting SARS-CoV-2, the virus that causes COVID-19, via a user’s breath. Instead of relying on a lab, the...more
Nephros, Inc. acquired GenArraytion, Inc., a manufacturer of infectious disease monitoring and measurement products. The acquisition is Nephros’s first medical products sector transaction....more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA revokes...more
In 2020, heightened demand for health care resulted in an influx of therapeutic goods being included on the Australian Register of Therapeutic Goods (ARTG). A large portion of these goods are manufactured in China however,...more
The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The SARS-CoV-2 virus has mutated over time,...more
The firm is pleased to present the latest edition of The Life Sciences Report. This issue features a sampling of recent COVID-19-related client activity in which the firm has been involved, an article on life sciences venture...more
On 11 January 2021, the European Commission published a Notice which provides the conditions under which remote audits under Regulation 2017/745 of 5 April 2017 on medical devices (MDR) and Regulation 2017/746 of the of 5...more
Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform....more
The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC...more
UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more
Join us as we celebrate the 25th Anniversary of ACI’s Annual Flagship Conference on Drug & Medical Device Litigation! ACI’s Drug and Medical Device Litigation has united the greatest minds of the pharmaceutical and medical...more
In Tuesday's Report: FDA lists essential medicines and medical countermeasures, Trump plans health official replacement, FDA expands remote monitoring exemption list, WHO director self-quarantines, and other U.S. White House...more
Because they are made up of human beings, they are imperfect organizations. But for decades, the federal Centers for Disease Control and Prevention (CDC) and the federal Food and Drug Administration (FDA) have won global...more