September 2014

Today, CMS launched its Open Payments System. The website went live at 2pm. Open Payments gives users the option of (1)…

After over four years since the passage of the Affordable Care Act, September 30th marks the date for the release of the…

FDA does not have “inherent reconsideration authority” to reclassify medical devices without notice and a comment…

The Justice Department announced last week that pharmaceutical company Shire Pharmaceuticals LLC will pay $56.5 million to…

In August, House Ways and Means Subcommittee on Health Chairman, Kevin Brady (R-TX), released the Protecting Integrity in…

A recent editorial published in the Wall Street Journal entitled "Doctoring in the Age of ObamaCare" provides a glimpse…

An interesting False Claims Act issue cropped up in a recent $8 million settlement involving U.K.-based medical device…

The Food and Drug Administration has released a guidance document that offers insight into their decision-making when reviewing…

Pharmaceutical manufacturers routinely offer copayment coupons to reduce or eliminate the cost of patients'…

Life science trade associations PhRMA, Advamed, and BIO have sent a letter to the Centers for Medicare and Medicaid Services (CMS)…