Tag: FDA NTI guidelines

International Regulatory Approaches to NTI Generics: What Every Prescriber Needs to Know

Posted by Paul Fletcher
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International Regulatory Approaches to NTI Generics: What Every Prescriber Needs to Know

NTI generics require stricter regulation than standard generics due to narrow margins between effective and toxic doses. This article explores how the FDA, EMA, Canada, and Japan differ in their approaches, what’s changing in 2025, and why prescribers must stay cautious.

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