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Guidance on Microbial Vectors Used for Gene Therapy


Federal Register Notice: FDA is making available a draft document entitled Recommendations for Microbial Vectors Used for Gene Therapy; Draft Guidance for Industry. It provides investigational new drug application (IND) sponsors, with chemistry, manufacturing, and control information recommendations for IND submissions for microbial vectors used for gene therapy (MVGTs) in early-phase clinical trials. MVGTs meet the regulatory definition of “biological product”, when such products are applicable to the prevention, treatment, or cure of a disease or condition of human beings. The guidance also provides an overview of preclinical and clinical considerations for these products. When finalized, the draft guidance will supplement Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) dated 4/2008. To download this guidance, click here. To view this notice, click here.