Final Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products - U.S. Food & Drug Administration (FDA) CBER's Guidances Update -

Guidances for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Final Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products (PDF - 311KB)
Posted: 2/16/2011
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM243392.pdf