FDA Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products

https://www.gmp-navigator.com/files/guidemgr/FDA Guidance for Industry Potency Tests for Cellular and Gene Therapy Products.pdf

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM243392.pdf