Regulations.gov document
Reference 1 Content and Review of Chemistry, Manufacturing, and Control (CMC) Information…
Supporting & Related Material · FDA-2013-D-0576 · posted Jun 11, 2015
Key facts
| Document ID | FDA-2013-D-0576-0021 |
|---|---|
| Title | Reference 1 Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications re Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-2013-D-0576 |
| Posted | Jun 11, 2015 |
At a glance
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