Document Detail


US regulation of combination products.
MedLine Citation:
PMID:  20302139     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The successful launch ofa combination product in the United States (US) will depend on how well a company understands applicable US regulations and policies, which differ in important ways from requirements in Europe. This article provides an overview of useful information on the US regulation of these products that can be found on the newly redesigned Food and Drug Administration website.
Authors:
Maria Donawa
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Medical device technology     Volume:  20     ISSN:  1048-6690     ISO Abbreviation:  Med Device Technol     Publication Date:  2009 Oct 
Date Detail:
Created Date:  2010-03-22     Completed Date:  2010-04-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9215490     Medline TA:  Med Device Technol     Country:  England    
Other Details:
Languages:  eng     Pagination:  22, 24-5     Citation Subset:  T    
Affiliation:
Donawa Lifescience Consulting, Rome, Italy. medonawa@donawa.com
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MeSH Terms
Descriptor/Qualifier:
Device Approval / legislation & jurisprudence*
Drug Approval / legislation & jurisprudence*
Drug Combinations*
Equipment and Supplies / standards*
Government Regulation
Guideline Adherence / legislation & jurisprudence,  standards
Guidelines as Topic*
United States
United States Food and Drug Administration*
Chemical
Reg. No./Substance:
0/Drug Combinations

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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