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FDA Draft Guidance for Industry Recommendations for Microbial Vectors used for Gene Therapy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,

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Draft Guidance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.

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