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Latest report   February 2025

Safety Observer 219

EMA issues final guideline on specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQs).

Released 04-Feb-2025

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Past Reports

Safety Observer 218
European Commission issues draft revisions to Implementing Regulation (EU) N°520/2012..
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Safety Observer 217
ICH has published Annex 2 of the E6(R3) draft Guideline on GCP for public consultation..
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Safety Observer 216
The FDA has published the final guidance on Neurodevelopmental Safety Studies in Neonates..
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