Regulations.gov document
Reference 1 Guidance for FDA Reviewers and Sponsors Content and Review of Chemistry…
Supporting & Related Material · FDA-2015-D-3399 · posted Oct 15, 2015
Key facts
| Document ID | FDA-2015-D-3399-0004 |
|---|---|
| Title | Reference 1 Guidance for FDA Reviewers and Sponsors Content and Review of Chemistry Manufacturing and Control CMC Information for Human Gene Therapy Investigational New Drug Applications INDs 2008 re Recommendations for Microbial Vectors used for Gene Therapy Draft Guidance for Industry |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-2015-D-3399 |
| Posted | Oct 15, 2015 |
At a glance
- 1–9 Public comments on this docket
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