FDA guidance
Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and…
FDA guidance · Final · issued May 5, 2026
Key facts
| Title | Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application: Guidance for Industry |
|---|---|
| Status | Final |
| Issue date | May 5, 2026 |
| Center | Center for Biologics Evaluation and Research |
| Issuing office | Center for Biologics Evaluation and Research |
| Communication type | Guidance Document |
| Regulated product | Biologics |
| Docket number | FDA-2026-D-4692 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- None Product codes referenced
- None Recognized standards referenced
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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