Last week, the U.S. Food and Drug Administration (FDA) published the proposed rule “Medication Guides: Patient Medication Information,” which would significantly change the agency’s prescription drug product labeling...more
The Fourth Circuit has found that a West Virginia state law restricting how attorneys can solicit clients in pharmaceutical and medical device cases does not violate the First Amendment. At the end of April, a three-judge...more
5/19/2022
/ Advertising ,
Attorney Advertising ,
Commercial Speech ,
Constitutional Challenges ,
Federal Trade Commission (FTC) ,
First Amendment ,
FTC Act ,
Law Practice Management ,
Medical Devices ,
Prescription Drugs ,
Unfair or Deceptive Trade Practices
During the past 12 months, we’ve published several articles on the 10 March 2020, Public Readiness and Emergency Preparedness Act (PREP Act) Declaration related to COVID-19 as well as covering the five amendments to the PREP...more
New Sustainable Batteries Regulation: Reflections from our Global Products Law team
Following the closure of the European Commission’s recent consultation period, the European Parliament and Council are set to consider a...more
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
On January 28, 2021, the U.S. Department of Health and Human Services (“HHS”) issued its fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) related to COVID-19...more
On 18 February 2020, the French Ministry of Economy and Finance announced the launch of a new online platform called SignalConso, an easy-to-use public service enabling individuals to report any consumer law issue they may...more
Earlier this year, we published various articles breaking down the March 10, 2020 Public Readiness and Emergency Preparedness Act (PREP Act) Declaration (the Declaration) related to COVID-19....more
On Monday, the U.S. Department of Health and Human Services (HHS) issued a second amendment (the Amendment) to the March 10, 2020 Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Medical...more
We're excited to bring you issue 77 of our "International products law review" with insights and updates on all aspects of products law. In this issue, provide updates on COVID-19, address promoting the circular economy...more
6/1/2020
/ Consumer Product Companies ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Drones ,
EU ,
Medical Devices ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Safety Standards ,
Smart Devices ,
Soda Tax ,
Supply Chain ,
Tax Planning
On April 14, 2020, the Department of Health and Human Services (HHS) General Counsel issued an advisory opinion (“the Opinion”) on the March 10, 2020 Public Readiness and Emergency Preparedness Act (“PREP Act”) Declaration...more
On April 8, 2020, the Office of Assistant Secretary for Health (OASH), in the U.S. Department of Health and Human Services (HHS) issued Guidance for Licensed Pharmacists, COVID-19 Test, and Immunity Under the PREP...more
While numerous entities are responding with impressive speed and diligence in working to develop and deploy various COVID-19 countermeasures, some from the Plaintiffs bar are already putting up online advertisements offering...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
3/17/2020
/ Biopharmaceutical ,
Biotechnology ,
Centers for Disease Control and Prevention (CDC) ,
China ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Infectious Diseases ,
Institutional Review Board (IRB) ,
Italy ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Netherlands ,
Public Health ,
Reimbursements ,
Research and Development ,
Supply Chain ,
Travel Restrictions ,
Trump Administration ,
UK ,
Vaccinations ,
Vendors ,
World Health Organization
We are excited to bring you issue 76 of our International Products Law Review with insights and updates on all aspects of products law. In this issue, we explore what businesses need to consider when making climate-related...more
1/13/2020
/ Appeals ,
Business Litigation ,
Carbon Emissions ,
Causation ,
Class Action ,
Climate Change ,
Consent ,
Consumer Protection Laws ,
Cookies ,
Court of Justice of the European Union (CJEU) ,
Cybersecurity ,
Disclosure ,
Energy Efficiency ,
EU ,
European Court of Justice (ECJ) ,
Evidence ,
Germany ,
GlaxoSmithKline ,
Legislative Agendas ,
Litigation Funding ,
Litigation Strategies ,
Multidistrict Litigation ,
Opioid ,
Opt-In ,
Pharmaceutical Industry ,
Prescription Drugs ,
Project Management ,
Regulatory Agenda ,
Vaccinations
We are excited to bring you the latest issue of our International Products Law Review with insights and updates on all aspects of products law. In this issue, we explore the trustworthiness of AI, a consumer whistleblowing...more
11/1/2019
/ Appeals ,
Artificial Intelligence ,
Class Action ,
Court of Justice of the European Union (CJEU) ,
Cybersecurity ,
EU ,
Evidentiary Standards ,
Global Market ,
Medical Devices ,
Punitive Damages ,
Regulatory Agenda ,
Restaurant Industry ,
Retail Market ,
UK ,
Whistleblowers
Opinion highlights importance of a "clear" record at FDA -
On 20 May the U.S. Supreme Court unanimously ruled that federal preemption questions arising under the Federal Food, Drug, and Cosmetic Act (FD&C Act) are for a...more
5/30/2019
/ Agency Disapproval ,
Clear Evidence Standard ,
Failure To Warn ,
FDA Approval ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Jury Trial ,
Manufacturers ,
Merck Sharp & Dohme Corp. v. Albrecht ,
Preemption ,
Prescription Drugs ,
Question of Fact ,
Question of Law ,
Remand ,
SCOTUS ,
State Law Claims ,
Vacated ,
Warning Labels