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Business · 08/07/1997Updated: 10/17/2026 · 1 min read

FDA Announces Revised Form 356h for New Drug, Biologic, or Antibiotic Applications

Summary

The Food and Drug Administration (FDA) has released a revised version of Form FDA 356h, designed to streamline the application process for new drugs, biologics, and antibiotics, aiming to reduce review time and burdens on industry while maintaining public health protection.

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

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