Ad Law Tool Kit Show – Episode 1 – Product Safety and Recalls
Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
On August 5, 2025, Royal Sovereign International, Inc. reached a civil and criminal resolution with the United States Department of Justice (DOJ) that includes a $16.025 million civil penalty—the maximum authorized under the...more
A recent federal decision has made clear that court-ordered recalls can have real teeth, not just for manufacturers but also their officers—especially when the court has reason to suspect a company’s execs are deliberately...more