FDA guidance
A Guide to Informed Consent: Guidance for Institutional Review Boards and Clinical…
FDA guidance · Final · issued Jan 1, 1998
Key facts
| Title | A Guide to Informed Consent: Guidance for Institutional Review Boards and Clinical Investigators |
|---|---|
| Status | Final |
| Issue date | Jan 1, 1998 |
| Center | Office of the Commissioner |
| Issuing office | Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice |
| Communication type | Information Sheet |
| Regulated product | Biologics, Drugs, Medical Devices |
| Open for comment | No |
At a glance
- None Product codes referenced
- 1–9 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