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This determination was based on chronic toxicity studies, genotoxicity studies, and human clinical trial safety data
These atypical presentations warrant evaluation to exclude drug-unrelated causes such as viral infection, autoimmune conditions, or electrolyte imbalance
September 2025 : Europes EMA published a Reflection Paper on AI in the Medicinal Product Lifecycle (published Sept 30, 2024) ( [32] ), following a public consultation earlier in 2023
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