FDA issues final guidance for cell and gene therapy manufacturers
The FDA today issued final guidance for cellular and gene therapy (CGT) manufacturers, replacing its 2011 potency testing guidance and recommending a Potency Assurance Strategy for products treating serious or life-threatening conditions. The FDA will host a webinar on December 10, 2026 to help stakeholders understand and implement the guidance.
Primary source
FDA press announcement, November 2, 2026
FDA Provides Clarity to Support Cell and Gene Therapy Development and Quality
Read the source: FDA Provides Clarity to Support Cell and Gene Therapy Development and Quality fda.gov
Machine-summarized from the source above; not independently reported. How we use automation