April 2017

Thomas P. Stossel, MD, MD (Hon), is a visiting scholar at the American Enterprise Institute and professor emeritus at Harvard…

While False Claims Act cases are relatively common in the life science industry, FCA cases for cGMP violations are not. This…

As has been reported, the FDA is under pressure to speed up approval of generic medicines. In response, the FDA released data…

The Food and Drug Administration (FDA) has announced a public workshop to obtain input on issues and challenges associated with…

Dr. Lynn Webster of Utah recently produced a documentary about pain treatment. The documentary, “The Painful Truth,” can be found…

On January 11, 2017, the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services (HHS), issued a new…

Late last year, John Jenkins, director of the FDA’s Office of New Drugs told attendees at an event that the decline in new drug…

The Maryland House recently passed a bill – House Bill 631 – with the goal of “prohibiting a manufacturer or wholesale distributor…

Amy Greenstein, Senior Consultant and Dana Liu, Consultant, Polaris The PRC continues to focus on three principle life science…

In early March 2017, Senator Chuck Grassley sent a letter to the manufacturer of Auvi-Q (an epinephrine injector similar to…