By Dara Katcher Levy – Last week, FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) released an Untitled Letter issued to Novartis on May 31st, which alleges the company made unsubstantiated superiority claims in a detail aid for its ADHD drug, Focalin XR. Unlike most …
By Jeffrey N. Wasserstein – As aficionados of all things social media (see our prior postings here, here, here, and here) (other than kitten videos, enough with those already!) we couldn’t help but notice a recent Untitled Letter to Warner Chilcott, LLC, relating to a YouTube video. A …
By Dara Katcher Levy – FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) has announced that it will be holding a series of Enforcement Webinars that will provide an opportunity for attendees to ask DDMAC questions about the Warning and Untitled Letters it issues each …
Hyman, Phelps & McNamara's Jeffrey N. Wasserstein (co-founder of the FDA Law Blog) will be moderating a panel on social media and therapeutic products at the FDLI Annual Meeting, April 5-6, 2011, at the Ronald Reagan International Trade Center, in Washington, DC. The panel will …
By Nisha P. Shah & Alan M. Kirschenbaum – In an unusual step, the State of California’s Department of Insurance intervened in a qui tam lawsuit brought against Bristol-Myers Squibb (“BMS”) by three former employees, including a former member of the L.A. Lakers. In The People …
By Jeffrey N. Wasserstein – As our loyal blog readers know, we are great fans of social media, and follow these topics in earnest (here, here, and here). We have just learned that the long-awaited FDA guidance that was promised to come out by year-end will …
