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
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
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