Research 🇬🇧 Important for Genetic Diseases generally

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

person U.S. Food and Drug Administration

calendar_today Nov 2, 2026

The FDA issued final guidance for cell and gene therapy manufacturers on a Potency Assurance Strategy: science- and risk-based testing to verify each batch is biologically active as intended before patient use. This is regulatory guidance, not a new clinical finding, and may affect development quality standards for therapies for rare and serious diseases.