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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…

Co-authors: 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…

Co-authors: 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…

Co-authors: Thomas W. Beimers.

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