منابع مشابه
The impact of Wyeth v. Levine on FDA regulation of prescription drugs.
In Wyeth v. Levine, decided in March, 2009, the United States Supreme Court concluded that the plaintiff's failure to warn claim against the makers of the drug Phenergan was not impliedly preempted by the Food, Drug and Cosmetic Act. In doing so, the Court rejected the argument of the U.S. Food and Drug Administration (FDA) that tort claims of this nature stand as an obstacle to federal regulat...
متن کاملPLIVA v. Mensing: generic consumers' unfortunate hand.
INTRODUCTION ................................................................................................ 210 I. DRUG APPROVAL PROCESS .......................................................................... 213 A. BRAND-NAME DRUG APPROVAL AND LABELING PROCESS ..................... 213 1. PRE-APPROVAL ...................................................................................... 2...
متن کاملPost-decision diagnosis: medical device preemption alive and mostly well after Medtronic, Inc. v. Lohr.
In Medtronic, Inc. v. Lohr, the United States Supreme Court, in a five-to-four split, held that the Medical Device Amendments of 1976 did not preempt state tort claims against a pacemaker manufacturer. A careful reading of the factually specific holding of this case suggests that manufacturers of medical devices distributed pursuant to premarket approval requirements and investigational device ...
متن کاملMike Levine
Mike Levine is at the University of California, Berkeley where he is coDirector of the newly formed Center for Integrative Genomics. He obtained his Ph.D. from Yale University with Alan Garen studying steroid-regulated gene expression in Drosophila larvae. As a Jane Coffin Childs fellow he did postdoctoral research with Walter Gehring at the University of Basel in 1982. After a second short pos...
متن کاملLown-Ganong-Levine syndrome.
His bundle recordings were obtained in three patients with histories of recurrent supraventricular tachyeardias and electrocardiograms demonstrating a short P-R interval with a normal QRS (the Lown-Ganong-Levine syndrome). The His bundle electrograms obtained during sinus rhythm demonstrated a normal A-H (atrium-to-His bundle) time in one patient and a low normal A-H time in two patients. The H...
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ژورنال
عنوان ژورنال: SSRN Electronic Journal
سال: 2009
ISSN: 1556-5068
DOI: 10.2139/ssrn.1409678