FDA guidance
Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells…
FDA guidance · Final · issued Feb 23, 1996
Key facts
| Title | Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products |
|---|---|
| Status | Final |
| Issue date | Feb 23, 1996 |
| Center | Center for Drug Evaluation and Research |
| Issuing office | Center for Drug Evaluation and Research |
| Communication type | Guidance Document |
| Regulated product | Drugs |
| Docket number | FDA-1995-D-0245 |
| 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