Tag: pharmaceutical industry

Online Health Law Graduate Certificate Programs

Filed in Health Law by on May 8, 2013 0 Comments
Online Health Law Graduate Certificate Programs
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Center for Health & Pharmaceutical Law & Policy Introduces First Edition of Pharmaceutical and Medical Device Compliance Manual

Filed in Compliance, Health Law by on January 16, 2013 0 Comments
Center for Health & Pharmaceutical Law & Policy Introduces First Edition of Pharmaceutical and Medical Device Compliance Manual
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The Seton Hall Law Center for Health & Pharmaceutical Law & Policy, American Health Lawyers Association (AHLA) and the Food and Drug Law Institute (FDLI) have released the first edition of the Pharmaceutical and Medical Device Compliance Manual. The Manual is a guide to deciphering the intricate web of federal and state laws and the […]

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Research Fellow & Lecturer in Law Kate Greenwood in a Featured Op-ed in Pharmalot on the U.S. Supreme Court and Liability for Defects in Generic Drugs

Filed in Health Law, Uncategorized by on December 11, 2012 1 Comment
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Research Fellow & Lecturer in Law Kate Greenwood published a Featured Op-ed in Pharmalot on the U.S. Supreme Court and the prospect of liability for personal injury from defects in generic drugs. In “Betting on Liability for Generic Defects,” Greenwood writes: As reported on Pharmalot, the US Supreme Court has agreed to review the First […]

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United States v. Caronia: Some Preliminary Thoughts on the Second Circuit’s Decision Invalidating the Ban on Off-Label Promotion

Filed in Health Law by on December 4, 2012 2 Comments
United States v. Caronia: Some Preliminary Thoughts on the Second Circuit’s Decision Invalidating the Ban on Off-Label Promotion
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Earlier this week, the Second Circuit Court of Appeals at last issued its decision in United States v. Caronia and it is momentous (and predicted to be heading to the Supreme Court).  A two-judge majority of the Circuit Court held that Alfred Caronia, a pharmaceutical sales representative, “was convicted for his speech – for promoting […]

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Canaries in a Coal Mine: Patient Complaints (Finally) Lead to Withdrawal of Generic Wellbutrin XL

Canaries in a Coal Mine:  Patient Complaints (Finally) Lead to Withdrawal of Generic Wellbutrin XL
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Recently, the Food and Drug Administration announced that the manufacturer Impax Laboratories has asked the agency to withdraw its approval of a generic version of the antidepressant Wellbutrin XL 300 mg that is manufactured by Impax and marketed by Teva Pharmaceuticals.  A bioequivalence study sponsored by the FDA compared the Impax/Teva 300 mg generic to […]

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