Research Catalog

Title

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

Publication

[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2008]

Details

Additional Authors

Center for Biologics Evaluation and Research (U.S.)

Description

i, 15 pages : digital, PDF file

Alternative Title

Potency tests for cellular and gene therapy products

Subject

• Cellular therapy > Testing
• Gene therapy > Testing

Note

• Title from PDF title page (viewed on Mar. 24, 2009).
• "Draft guidance."
• "October 2008."
• Includes bibliographical references (p. 14-15).

System Details (note)

• Mode 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.

Call Number

GPO Internet HE 20.4802:C 33

OCLC

marcive316875920

Title

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

Publisher

[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2008]

Type of Content

text

Type of Medium

computer

Type of Carrier

online resource

System Details

Mode 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.

Connect to:

https://purl.fdlp.gov/GPO/LPS110622

Added Author

Center for Biologics Evaluation and Research (U.S.)

Gpo Item No.

0499-T-02 (online)

Sudoc No.

HE 20.4802:C 33