| Should preemption apply in a pharmaceutical context? An analysis of the preemption debate and what regulatory compliance statutes contribute to the discussion. | |
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MedLine Citation:
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PMID: 18982554 Owner: HSR Status: MEDLINE |
Abstract/OtherAbstract:
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Should the Food and Drug Administration (FDA)'s determination that a product is safe negate a private litigant's cause of action under state law in all circumstances, unless the FDA determines that the manufacturer withheld relevant information regarding the safety of the product? This Note concludes that such federal preemption is proper because the FDA is fully capable of making a determination regarding the adequacy of the information disclosed by a pharmaceutical manufacturer without state interference. Additionally, such interference on the state level hinders the FDA's objectives and effective functioning. Thus, determinations about the adequacy of the information provided to the FDA should remain in the Agency's sound discretion and not be questioned at the state level. |
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Authors:
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Jennifer A Surprenant |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Fordham law review / edited by Fordham law students Volume: 77 ISSN: 0015-704X ISO Abbreviation: Fordham Law Rev Publication Date: 2008 Oct |
Date Detail:
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Created Date: 2008-11-04 Completed Date: 2008-11-07 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9891707 Medline TA: Fordham Law Rev Country: United States |
Other Details:
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Languages: eng Pagination: 327-63 Citation Subset: T |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Access to Information
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legislation & jurisprudence* Consumer Product Safety / legislation & jurisprudence* Device Approval / legislation & jurisprudence Disclosure / legislation & jurisprudence* Drug Approval / legislation & jurisprudence Drug Industry / legislation & jurisprudence Drug Labeling / legislation & jurisprudence*, standards Duty to Warn / legislation & jurisprudence Government Regulation Humans Liability, Legal Patient Rights / legislation & jurisprudence*, standards State Government Supreme Court Decisions United States United States Food and Drug Administration / legislation & jurisprudence |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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