FDA Draft Guidance for Industry Recommendations for Microbial Vectors used for Gene Therapy
Title:
FDA Draft Guidance for Industry Recommendations for Microbial Vectors used for Gene Therapy
Origin/Publisher:
Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM466625.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery
Document Type:
Draft Guidance
Content:
provides investigational new drug application (IND) sponsors, with recommendations concerning IND submissions for microbial vectors used for gene therapy (MVGTs) in early-phase clinical trials.