Guidance for FDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human gene 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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| Subjects: | |
| Online Access: | https://purl.fdlp.gov/GPO/LPS111884 |
| Item Description: | Title from PDF title page (viewed on Apr. 24, 2009). Title from title screen (viewed on Apr. 24, 2009). "April 2008". Electronic resource. |
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| Physical Description: | 1 online resource (ii, 34 pages) |
| Format: | Mode of access: Internet at the GPO Web site. Address as of 4/24/09: http://www.fda.gov/cber/gdlns/gtindcmc.pdf ; current access is available via PURL. |
| Bibliography: | Includes bibliographical references (pages 32-34). |