| International Conference on Harmonisation; guidance on data elements for transmission of individual case safety reports; availability. Notice. Food and Drug Administration, HHS. | |
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MedLine Citation:
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PMID: 12296373 Owner: HSR Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 63 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 1998 Jan |
Date Detail:
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Created Date: 2002-09-24 Completed Date: 2002-10-11 Revised Date: 2009-11-03 |
Medline Journal Info:
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Nlm Unique ID: 7808722 Medline TA: Fed Regist Country: United States |
Other Details:
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Languages: eng Pagination: 2396-404 Citation Subset: T |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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0/Drugs, Investigational |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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