Business · 15/08/1997Updated: 10/17/2026 · 1 min read

FDA Proposes New Regulations for Pediatric Drug and Biological Product Studies

Summary

The FDA is proposing new regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients, aiming to improve product labeling and increase the number of treatments available for children.

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

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