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Sponsored Artificial Intelligence: A Modern Approach, Global Edition Artificial Intelligence: A Modern Approach, Global Edition

Author

S. Mutta

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2 papers indexed here

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Review Sep 2026

Orphan drug regulation: a global comparison of the United States Food and Drug Administration, European Medicines Agency, and Japanese Pharmaceuticals and Medical Devices Agency approaches.

OBJECTIVE To perform a comparative review of orphan drug policies and designation criteria implemented by the US Food and Drug Administration, the European Medicines Agency, and Japan's Pharmaceuticals and Medical Devices Agency, assessing their influence on development, approval, and access. METHOD A targeted review...

R. Elango, Russell Martin, S. Mutta · 0 citations
Review Sep 2026

In Silico Medicine: The Regulatory Gap in AI-Driven Drug Development

In silico medicine, which depends on computational modeling and simulation, is becoming more popular in drug discovery worldwide. Biomedical research is being rapidly transformed by Artificial Intelligence (AI), but there are risks associated with regulatory ambiguity. The integration of AI offers significant oppor...

S. Mutta, Naifa Faiz, T. N. et al. · 0 citations

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