All posts by Sarah K. diFrancesca

LITIGATION ROUND-UP

Settlements The U.S. Department of Justice (DOJ) announced on July 18, 2013 that pharmaceutical manufacturer Mallinckrodt LLC agreed to pay $3.5 million to settle a civil False Claims Act suit. The complaint alleged that Mallinckrodt paid illegal kickbacks to health care professionals in the form of speaker honoraria, clinical trials funding, and honoraria […]

FDA Issues Draft Guidance on Reporting Adverse Events for Medical Device Manufacturers

The Food and Drug Administration Center for Devices and Radiological Health released draft guidance on July 9, 2013 titled, Medical Device Reporting for Manufacturers.  Written comments may be submitted by mail or electronically to the FDA within 90 days.  When finalized, the guidance will supercede the 1997 guidance document with the […]

No Relief in Minnesota from Reporting Obligations

On June 24, 2013, the Minnesota Board of Pharmacy posted a letter to pharmaceutical manufacturers and drug wholesalers informing them that the Board’s request to the Minnesota legislature to repeal Minnesota Stat. §151.47(1)(f) did not occur. Rather, the Minnesota legislature modified the statute related to reporting obligations. The Minnesota Board […]