Yesterday, we reported that FDA had announced its intentions of reclassifying sunlamp products and requiring labeling changes to include warnings discouraging young people from using them....more
Harsh Criticism for Ad Industry Over DNT - The advertising industry faced harsh criticism at a hearing held by Sen. Jay Rockefeller (D-W.V.). He addressed the implementation of a federal Do Not Track program and...more
After issuing a public warning regarding the dangers of tanning nearly three years ago, this week the U.S. Food and Drug Administration (“FDA”) issued a proposed order to reclassify sunlamp devices and require labeling...more
The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13,...more
Today, the Supreme Court of the United States held oral argument in Mutual Pharmaceutical Co. v. Bartlett, a follow-up to its landmark ruling in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), which addressed federal...more
The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more
In October 2009, we published the first edition of this White Paper, focusing primarily on social media issues in the United States. The response was overwhelming and far beyond our expectation — clients, friends, press and...more
On April 29-30, 2013, FDA will hold a public workshop to discuss standardizing the format and content of medical device labeling and the development of a public repository/database that would provide access to the labeling of...more
After a year that saw labeling issues come to the forefront of the food safety conversation, I sat down with DLA Piper trial lawyer Stefanie Fogel to get her take on how manufacturers, producers, and retailers can expect the...more
On September 10, 2012, the U.S. Food and Drug Administration (FDA) released a draft compliance policy guide (“CPG”) entitled “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat...more
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