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Business · 02/12/1998Updated: 10/17/2026 · 1 min read

FDA Issues New Regulations for Pediatric Drug and Biological Product Studies

Summary

The Food and Drug Administration (FDA) is introducing new rules requiring pharmaceutical companies to conduct safety and effectiveness tests on new drugs and biological products in children, in an effort to improve product labeling and ensure safe use in pediatric patients.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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