FDA guidance
Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain…
FDA guidance · Final · issued Jun 21, 2021
Key facts
| Title | Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products: Guidance for Industry |
|---|---|
| Status | Final |
| Issue date | Jun 21, 2021 |
| Center | Center for Biologics Evaluation and Research |
| Issuing office | Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research |
| Communication type | Guidance Document |
| Docket number | FDA-1995-D-0288 |
| 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