Guidance for industry : potency tests for cellular and gene therapy products.

Other author Center for Biologics Evaluation and Research (U.S.)
Format Electronic
Publication Info[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2008]
Descriptioni, 15 p. : digital, PDF file
Supplemental Contenthttps://purl.fdlp.gov/GPO/LPS110622
Subjects

Portion of title Potency tests for cellular and gene therapy products
General noteTitle from PDF title page (viewed on Mar. 24, 2009).
General note"Draft guidance."
General note"October 2008."
General noteIncludes bibliographical references (p. 14-15).
General noteGPO Cataloging Record Distribution Program (CRDP).
Technical detailsMode of access: Internet at the FDA Web site. Address as of 3/24/09: http://www.fda.gov/cber/gdlns/testcellgene.pdf ; current access is available via PURL.
GPO item number0499-T-02 (online)
Govt. docs number HE 20.4802:C 33