Litigation

Recent Posts

Norton Rose Fulbright: FDA’s Expanded Oversight Of ‘High-risk’ Diagnostic Devices
Posted on 7 Aug 2014 by Norton Rose Fulbright

By Cori Annapolen Goldberg and Lidia Niecko-Najjum In efforts to ensure that in vitro diagnostic devices 1 provide accurate, consistent and reliable results, the US Food and Drug Administration ("FDA" or "the Agency") 1) issued... Read More

Ballard Spahr LLP: Pharmaceutical Companies Get Off-Label Marketing Victory
Posted on 18 Aug 2015 by Ballard Spahr LLP

. . . A federal judge ruled that the Food and Drug Administration (FDA) cannot prohibit a pharmaceutical company from marketing its drugs for off-label uses if its claims are truthful and not misleading. This ruling, while not precedential, alters the... Read More