FDA guidance
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in…
FDA guidance · Draft · issued Aug 6, 2015
Key facts
| Title | Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs |
|---|---|
| Status | Draft |
| Issue date | Aug 6, 2015 |
| Center | Center for Drug Evaluation and Research |
| Issuing office | Center for Veterinary Medicine, Center for Drug Evaluation and Research, Office of Regulatory Policy, Center for Biologics Evaluation and Research |
| Communication type | Guidance Document |
| Regulated product | Drugs |
| Docket number | FDA-2004-D-0500 |
| Comments close | Oct 5, 2015 |
| 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