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…

Co-authors: Shahnam Sharareh, PharmD, RAC.

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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…

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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…

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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…

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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…

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