FDA guidance
A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers…
FDA guidance · Final · issued Apr 12, 2023
Key facts
| Title | A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers: Guidance for Industry |
|---|---|
| Status | Final |
| Issue date | Apr 12, 2023 |
| Center | Center for Drug Evaluation and Research |
| Issuing office | Office of Inspections and Investigations, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, Center for Drug Evaluation… |
| Communication type | Guidance Document |
| Regulated product | Biologics, Drugs, Medical Devices |
| Docket number | FDA-2019-D-0362 |
| 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