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
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 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
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
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