FDA guidance
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy…
FDA guidance · Final · issued Jan 28, 2020
Key facts
| Title | Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry |
|---|---|
| Status | Final |
| Issue date | Jan 28, 2020 |
| Center | Center for Biologics Evaluation and Research |
| Issuing office | Center for Biologics Evaluation and Research |
| Communication type | Guidance Document |
| Regulated product | Biologics |
| Topics | Cellular & Gene Therapy |
| Docket number | 2008-D-0205 |
| Comments close | Oct 10, 2018 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- None Product codes referenced
- None Recognized standards referenced
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA guidance documents
FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.
Source: U.S. Food and Drug Administration (FDA), Guidance Documents