LexisNexis® Legal Newsroom
Podcast: Marketing Medical and Consumer Products in Social Media

The Internet is now one of the most popular ways Americans obtain information on medical and consumer products. The emergence and growth of social media have changed traditional notions of what is regulated, who is responsible for product-related messaging, how reporting and regulatory obligations are...

Barnes & Thornburg LLP Health Blog: New Requirements for Informed Consent Effective March 7, 2012

By Carolyn Metnick In the Federal Register of January 4, 2011 (76 FR 256), the FDA published a final regulation amending the current informed consent regulation to require that informed consent documents and processes for applicable drug and device clinical trials include a specific statement that...

Barnes & Thornburg LLP: Amarin Pharma Preemptively Sues FDA over 1st Amendment Rights

On Thursday, May 7, Amarin Pharma took the unprecedented step of proactively suing the U.S. Food and Drug Administration (FDA) over the agency’s alleged infringement of the company’s First Amendment Rights. The case arises from Amarin’s desire to market its product, Vascepa, for uses...