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FDA releases modifications report

USA - February 27 2014 Earlier this week, FDA's Center for Devices and Radiological Health (CDRH) released its much-anticipate report to Congress on when a modification to...

D.C. Court of Appeals upholds FDA jurisdiction in Regenerative Sciences

USA - February 10 2014 Last week, the D.C. Court of Appeals upheld the FDA's District Court victory in United States v. Regenerative Sciences, LLC, No. 12-5254. The...

Ralph F. Hall.

Supreme Court denies cert in Harkonen

USA - December 19 2013 The Supreme Court denied certiorari this week in Harkonen v. United States. Harkonen was convicted of wire fraud related to statements he made in a...

Ralph F. Hall.

President Obama signs the Drug Quality and Security Act

USA - December 4 2013 On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA) into law. Title I of the Act establishes national standards for...

OIG special fraud alert warns physician owned distributors of enforcement actions

USA - April 12 2013 The Department of Health and Human Services' Office of Inspector General (OIG) recently released long-awaited guidance on Physician Owned...

Thomas W. Beimers.