Business · 24/06/2025Updated: 10/17/2026 · 1 min read

FDA Announces Draft Guidance for Stability Testing of Drug Substances and Products

Summary

The FDA has released a draft guidance for industry on Q1 stability testing of drug substances and products, a consolidated revision of previous ICH guidelines, to support marketing and regulatory applications.

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

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