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).
| Corporate Author: | |
|---|---|
| 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: | |
| Physical Description: | 1 online resource (ii, 34 pages) |
| Variant Title: |
Content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs) |
| Format: | Government Document Electronic eBook |
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