Document Detail


International Conference on Harmonisation; guidance on data elements for transmission of individual case safety reports; availability. Notice. Food and Drug Administration, HHS.
MedLine Citation:
PMID:  12296373     Owner:  HSR     Status:  MEDLINE    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is publishing a guidance entitled "E2B Data Elements for Transmission of Individual Case Safety Reports." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance is intended to facilitate the standardization of the data elements for the transmission of individual case safety reports for both preapproval and postapproval reporting periods.
Authors:
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  63     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  1998 Jan 
Date Detail:
Created Date:  2002-09-24     Completed Date:  2002-10-11     Revised Date:  2009-11-03    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2396-404     Citation Subset:  T    
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MeSH Terms
Descriptor/Qualifier:
Congresses as Topic
Drug Evaluation / standards*
Drugs, Investigational / adverse effects
European Union
Guidelines as Topic*
Humans
International Cooperation*
Japan
Medical Records / standards*
United States
United States Food and Drug Administration*
Chemical
Reg. No./Substance:
0/Drugs, Investigational

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


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