David Restaino

FDA seeks public comment on questions related to drug and biological product shortages

USA - February 13 2013 Pursuant to the Food and Drug Administration Safety and Innovation Act (FDASIA) signed into law on July 9, 2012, the Food and Drug Administration...

Shahnam Sharareh, PharmD, RAC.

State's "more stringent" Stark Law restrictions upheld by court

USA - January 30 2013 Today I am focusing on the self-referral ban under the federal Stark laws. In particular, a recent case - Fresenius Medical Care Holdings, Inc. v...

Green groups clash with business over NJ enviro waivers

USA - January 18 2013 A New Jersey appellate court is set to determine the fate of a controversial measure by the state's environmental regulator to waive land use...

OIG announces 2013 priorities

USA - January 3 2013 Now that the new year is upon us, today's post will look at the Department of Health and Human Services' Office of Inspector General (OIG), in particular...

Encouraging in-house disclosures in a whistleblower's world

USA - December 28 2012 Compliance officials have a great deal to worry about. They are judged by results and loaded with stress over the latest changes in government guidance...