FDA guidance
Benefit-Risk Considerations for Product Quality Assessments
FDA guidance · Draft · issued May 9, 2022
Key facts
| Title | Benefit-Risk Considerations for Product Quality Assessments |
|---|---|
| Status | Draft |
| Issue date | May 9, 2022 |
| 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-2022-D-0168 |
| Comments close | Jul 10, 2022 |
| 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