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Business · 12/05/2025Updated: 10/17/2026 · 1 min read

FDA Determines Regulatory Review Period for Patent Extension of Human Biological Product

Summary

The US Food and Drug Administration (FDA) has published a notice determining the regulatory review period for the extension of a patent claiming a human biological product, as required by law.

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

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