FDA guidance
Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their…
FDA guidance · Final · issued Jun 30, 2005
Key facts
| Title | Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process |
|---|---|
| Status | Final |
| Issue date | Jun 30, 2005 |
| Center | Center for Drug Evaluation and Research |
| Issuing office | Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research |
| Communication type | Guidance Document |
| Regulated product | Drugs |
| Docket number | FDA-2004-D-0440 |
| 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