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Fed Regist. 2014 Feb 21;79(35):9908-9.

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.


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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