Tag: narrow therapeutic index
NTI Generics: How Different Countries Regulate Narrow Therapeutic Index Drugs
NTI generics like warfarin and phenytoin require strict regulatory oversight due to their narrow safety margins. This article explores how the FDA, EMA, Health Canada, and other global regulators handle these drugs, including key differences in bioequivalence standards, approval processes, and real-world challenges.
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FDA Sentinel Initiative: How Big Data Detects Drug Safety Issues
2 February 2026 -
