Guidance for Human Somatic Cell Therapy and Gene Therapy | FDA

Docket Number: FDA-2009-D-0132-0016 Issued by:

Guidance Issuing Office

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.

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets ManagementFood and Drug Administration5630 Fishers Lane, Rm 1061Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0132-0016.

04/21/2021

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Guidance for Human Somatic Cell Therapy and Gene Therapy | FDA