Document Detail

Should preemption apply in a pharmaceutical context? An analysis of the preemption debate and what regulatory compliance statutes contribute to the discussion.
MedLine Citation:
PMID:  18982554     Owner:  HSR     Status:  MEDLINE    
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.
Jennifer A Surprenant
Related Documents :
11503864 - Clinical chemistry and clinical toxicology devices; classification of b-type natriureti...
17450664 - Laxative drug products for over-the-counter human use; psyllium ingredients in granular...
10182694 - Medical device reporting: manufacturer reporting, importer reporting, user facility rep...
11010634 - Medical devices; effective date of requirement for premarket approval for three preamen...
15702584 - Fat intake, diet variety and health promotion.
16415584 - Cathemerality in the mayotte brown lemur (eulemur fulvus): seasonality and food quality.
Publication Detail:
Type:  Journal Article    
Journal Detail:
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:
Created Date:  2008-11-04     Completed Date:  2008-11-07     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9891707     Medline TA:  Fordham Law Rev     Country:  United States    
Other Details:
Languages:  eng     Pagination:  327-63     Citation Subset:  T    
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Access to Information / 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
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

Previous Document:  Covering all kids: states setting the pace.
Next Document:  "Volume replacement" plus "dynamic support": a new regimen for effective burn shock resuscitation