Document Detail


International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; availability. Notice.
MedLine Citation:
PMID:  24611208     Owner:  HSR     Status:  In-Process    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation Guide--Data Elements and Message Specification'' (the E2B(R3) implementation guidance) and an appendix to the guidance entitled "ICSRs: Appendix to the Implementation Guide--Backwards and Forwards Compatibility'' (the BFC appendix). 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 E2B(R3) implementation guidance is intended to revise the standards for submission of ICSRs and improve the inherent quality of the data, enabling improved handling and analysis of ICSR reports. The BFC appendix describes the relationship between data elements from the 2001 ICH E2B guidance and the E2B(R3) implementation guidance.
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  79     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2014 Feb 
Date Detail:
Created Date:  2014-03-10     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  9908-9     Citation Subset:  T    
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