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Latest report  November 2025
Safety Observer 227
The US NCI published a new version of the CTCAE standard, which is used to grade the severity of AEs in oncology trials.
Released 05-Nov-2025
Past Reports
ICH has published the final revision of the E2D(R1) Guideline on Post-Approval Safety Data..
The EU has published final amendments to IR N°520/2012 on the performance of Pharmacovigilance activities..
A new draft of the EU Variations Guideline has been published, which will apply from 15-Jan-2026..
