Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under...more
On March 4, 2013, a panel of the United States Court of Appeals for the Ninth Circuit issued its opinion in United States v. Harkonen,1 a case in which the CEO of a pharmaceutical company was prosecuted for transmitting...more
The Ninth Circuit has reopened a door for off-label marketing prosecutions, and it is important to review your compliance and risk management programs in light of this recent decision. Last December, the pharmaceutical and...more
After two years of deliberation, the U.S. Second Circuit Court of Appeals has finally issued its decision in United States v. Caronia, holding that the government cannot prosecute pharmaceutical manufacturers or their...more
On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more