Long Term Follow-Up After Administration of Human Gene Therapy Products
Title:
Long Term Follow-Up After Administration of Human Gene Therapy Products
Origin/Publisher:
FDA Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@fda.hhs.gov, https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM610797.pdf
Document Type:
Guidance for Industry
Content:
Recommendations regarding the design of long term follow-up observational studies (LTFU observations) for the collection of data on delayed adverse events following administration of a GT product.