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GUIDANCE DOCUMENT

Recommendations for Microbial Vectors Used for Gene Therapy Guidance for Industry September 2016

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2015-D-3399
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA, are providing you, investigational new drug application (IND) sponsors, with recommendations concerning IND submissions for microbial vectors used for gene therapy (MVGTs) in early-phase clinical trials. MVGTs meet the definition of “biological product” in section 351(i) of the Public Health Service (PHS) Act (42 U.S.C. 262), when such products are applicable to the prevention, treatment, or cure of a disease or condition of human beings. This guidance focuses on the chemistry, manufacturing, and control (CMC) information that you should submit in an IND for MVGTs and provides an overview of preclinical and clinical considerations for these products.

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5630 Fishers Lane, Rm 1061
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All written comments should be identified with this document's docket number: FDA-2015-D-3399.

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