2017

Last week, Mylan Inc. and Mylan Specialty L.P. (hereinafter “Mylan”) reached an agreement with the United States Department of…

On July 7, 2017, the Ninth Circuit in a very closely watched opinion determined that the whistleblowers in this case had…

Congress has recently taken a few months off from constantly barraging the pharmaceutical industry with daily probes and negative…

Arizona was the first state to bite the bullet and allow pharmaceutical companies to communicate off-label uses of their drugs to…

In early 2017, FDA issued draft question and answer documents detailing how drug and device firms can discuss unapproved medical…

Further muddying the off-label waters is the fact that Congress has introduced several bills, attempting to legislate off-label…

We recently reported on the Senate’s passage of the FDA Reauthorization Act (FDARA) which renews and enhances the FDA drug,…

On May 11, 2017, Dr. Scott Gottlieb was sworn in as the U.S. Food and Drug Administration’s latest Commissioner. Since that time,…

Mid-July 2017, the United States Food and Drug Administration held a public meeting to discuss options and steps to encourage…

ExL Events is hosting the 5th Annual Promotional Review Committee Compliance & Best Practices conference on October 16–17,…