Longitudinal Descriptive Analysis of Dynamic Changes in Safety Concerns in Japanese Risk Management Plans for Medicinal Products Over 8 Years After Approval.

Ther Innov Regul Sci · 2025 · PMC12579639 · PMID 40739394

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showed a trendno p-value reported

Subgroup analyses showed a trend toward more changes in IIRs, IPRs, and IMIs in the group with additional approvals.

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