Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
The government’s FCA enforcement efforts have continued to focus on key areas concerning the pharmaceutical and medical device industries. In fact, drug and device manufacturers accounted for nearly half of the enforcement...more
In 1991, the Food and Drug Administration (FDA) approved Zofran, which is manufactured by GlaxoSmithKline LLC (GSK) for use in cancer patients who require chemotherapy or radiation therapy. An Ohio couple has sued GSK, the...more
On August 7, 2015, the U.S. District Court for the Southern District of New York released its Amarin opinion addressing whether truthful, non-misleading off-label promotion of U.S. Food and Drug Administration (FDA)-approved...more
It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more