2023.11.08Vol.5 No.13 FDA FDA ICH E2B(R3) Time Line at Webinar Quick Report & Follow-up Report on 7-Nov-2023(Tue) and 10-Nov-023(Fri)
2023.10.26Vol.5 No.11 FDA One FDA Regional Fields technical documentation on the FDA FAERS ICH E2B (R3) web page has been updated to 2023/10/25.
2023.10.11Vol.5 No.10 FDA As previously announced, registration for the FDA's Online Public Meeting (free) for ICH E2B (R3) Reporting is now open.
2023.09.14Vol.5 No.9 FDA The partial upload of the "FDA ICSR xml for E2B (R3) zip file" on the FDA FAERS Website was updated on 13th September 2023.
2023.06.06Vol.5 No.6 FDA FDA: upverion the FDA E2B(R3) Core and Regional Data Elements and Business Rules - Version 1.4.xlsx
2023.01.31Vol.5 No.4 FDA FDA: Updated "FDA Adverse Event Reporting System (FAERS) Electronic Submissions" on 31-Jan-2023
2022.08.17Vol.4 No.5 FDA FDA: updated ICH E2B(R3) Documents at Adverse Event Reporting System (FAERS) Electronic Submissions Website
2022.08.06Vol.4 No.3 FDA 2-Aug-2022: The FDA has issued a new draft guideline for ANDA.: Abbreviated New Drug Application in Bioavailability (BA)/ Bioequivalence (BE) studies
2022.08.06Vol.4 No.2 FDA 2022/7/6 Updated the Field Tag business rules as part of the FDA ICH E2B (R3) Guideline. The document to be updated is "FDA E2B (R3) Core and Regional Data Elements and Business Rules - Version 1.1" (Version Date as July -2022).
2021.11.03Vol.3 No.9 FDA updated : FDA Adverse Event Reporting System (FAERS) Electronic Submissions: Content current: as of 10/27/2021
