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Potency Tests for Cellular and Gene Therapy Products Final Guidance for Industry: January 2011

Docket Number:
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA, are issuing this guidance to provide you, manufacturers of cellular and gene therapy (CGT) products, with recommendations for developing tests1 to measure potency.2 These recommendations are intended to clarify the potency information that could support an Investigational New Drug Application3 (IND) or a Biologics License Application4 (BLA). Because potency measurements are designed specifically for a particular product, this guidance does not make recommendations regarding specific types of potency assays, nor does it propose acceptance criteria for product release. This guidance is intended to supplement related documents (Refs. 1 through 12) and does not replace or supersede any currently published guidance documents, with the exception that this guidance finalizes the draft guidance entitled “Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products” dated October 2008 (October 9, 2008, 73 FR 59635).

Submit Comments

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 Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2008-D-0520.


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