FDA releases proposed food safety rules: new standards would address foodborne illness and produce safety *

USA - January 8 2013
On January 4, 2013, the U.S. Food and Drug Administration (FDA or Agency) announced the release of two highly anticipated proposed rules affecting the…

Co-authors: Sharon M. Bradley, Colleen Heisey, Allison Reschovsky.

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Off-label marketing conviction violates First Amendment *

USA - December 6 2012
A divided panel of the Second Circuit Court of Appeals in New York overturned on First Amendment grounds the conviction of a pharmaceutical sales representative for conspiracy to introduce a misbranded drug into interstate commerce, an offense more commonly referred to as off-label marketing.

Co-authors: Patricia Acosta, Gary C. Messplay, Thomas R. Julin, Terence G. Connor, Jamie Zysk Isani.

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FDA issues draft guidance on refuse to accept policy for 510(k)s *

USA - August 17 2012
On August 13, 2012, the Food and Drug Administration announced the availability of a draft guidance titled “Refuse to Accept Policy for 510(k)s”.

Co-authors: D. Kyle Sampson, Brian J. Wesoloski.

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Government announces largest health care fraud settlement in U.S. history; GlaxoSmithKline, LLC, enters corporate integrity agreement with novel provisions *

USA - July 11 2012
Yesterday, the U.S. Department of Justice announced that GlaxoSmithKline, LLC (“GSK”), would pay $3 billion in criminal and civil penalties to resolve multiple investigations into the company’s sales, marketing and pricing practices for nine of its drugs.

Co-authors: Gary C. Messplay, D. Kyle Sampson, John Delionado.

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FDA considers a new prescription drug paradigm *

USA - March 1 2012
Under Section 503(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act, a drug must be dispensed by prescription if safe use of the drug requires supervision by a licensed health care professional.

Co-authors: Sharon M. Bradley, Colleen Heisey.

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