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FDA Press Releases·

FDA Provides Clarity to Support Cell and Gene Therapy Development and Quality

  • The U.S. Food and Drug Administration issued final guidance on November 2, 2026, requiring manufacturers of cellular & gene therapy products to implement a science- & risk-based plan for potency standards.
  • The new "Potency Assurance Strategy" replaces the FDA's 2011 guidance & mandates that every product batch meets defined therapeutic standards before reaching patients.
  • The guidance applies to treatments for serious & life-threatening conditions, ensuring compliance with laws requiring product verification from approval through post-market monitoring.
  • Recommendations cover integrating potency considerations across all development stages, including controls for raw material variability, manufacturing testing, & lab confirmation of biological activity.
  • Specialized provisions address products with short shelf lives, viral vector gene therapies, & patient-specific treatments.
  • The FDA aims to provide a predictable roadmap to support faster access to safe therapies while advancing patient safety, innovation, & supply chain integrity.
  • The FDA will host a webinar on December 10, 2026, to assist stakeholders in understanding & implementing the new guidance.