Guidance for Human Somatic Cell Therapy and Gene Therapy Guidance for Industry March 1998

GUIDANCE DOCUMENT

• Docket Number: FDA-2009-D-0132-0016
• Issued by: Center for Biologics Evaluation and Research

Since the issuance of the "Points to Consider (PTC) in Human Somatic Cell Therapy and Gene Therapy"in 1991, the range of gene therapy proposals has expanded to include additional classes of vectors and use of vectors in vivo via direct vector administration to patients. This guidance document updates and replaces the 1991 PTC with new information intended to provide manufacturers with current information regarding regulatory concerns for production, quality control testing, and administration of recombinant vectors for gene therapy; and of preclinical testing of both cellular therapies and vectors. These guidances are not regulations, but rather represent issues that the Center for Biologics Evaluation and Research (CBER) staff believes should be considered at this time.

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