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# Guidance on Gene Therapy Microbial Vector Recommendations
- URL: https://www.fdaweb.com/guidance-on-gene-therapy-microbial-vector-recommendations/
- Published: 2016-09-16T12:00:00.000Z
- Updated: 2026-09-14T21:32:33.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136832

*Federal Register* Notice: FDA has released a guidance on “Recommendations for Microbial Vectors Used for Gene Therapy” that provides recommendations concerning IND submissions for microbial vectors used for gene therapy in early phase clinical trials. The guidance focuses on the chemistry, manufacturing, and control information that sponsors should submit in an IND for such products, and provides an overview of preclinical and clinical considerations. To view the guidance, click [here](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM466625.pdf?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-09-16/pdf/2016-22353.pdf?ref=fdaweb.com).