Sunday, 10 January 2016

FDA Guide for Microbial Vectors used for Gene Therapy


New FDA draft guidance issued, titled “FDA Guide for Microbial Vectors used for Gene Therapy.”

The introduction reads:

“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 This draft guidance focuses on the chemistry, manufacturing, and control (CMC) information that you should submit in an IND for MVGTs and provides an overview of preclinical and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.

This draft guidance, when finalized, will supplement the guidance entitled, “Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control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 April 2008 (Ref. 1).

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required.”

For further details see: FDA

Posted by Dr. Tim Sandle