Guidance for FDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human somatic cell therapy investigational new drug applications (INDS).
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| Format: | Government Document eBook |
| Language: | English |
| Published: |
Rockville, MD :
U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,
[2008]
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| Online Access: | https://purl.fdlp.gov/GPO/LPS111878 |
| Item Description: | Title from PDF title page (viewed on Apr. 24, 2009). "April 2008". Electronic resource. |
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| Physical Description: | ii, 36 pages : digital, PDF file. |
| Format: | Mode of access: Internet at the FDA CBER Web site. Address as of 4/24/09: http://www.fda.gov/cber/gdlns/cmcsomcell.pdf ; current access is available via PURL. |
| Bibliography: | Includes bibliographical references (pages 27-29). |