# Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products —  Content and Format   Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/drug-abuse-and-dependence-section-of-labeling-for-human-prescription-drug-and-biological-products-content-and-format-guidance-for-industry/e65bdb77-e74c-42d7-aab4-482af24834d1

> FDA guidance document: Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products —  Content and Format   Guidance for Industry. Issue date: July 01, 2019. Get complete insights and analysis.

---

## Details

- Title: Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products —  Content and Format   Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2019-07-01
- Comment Close Date: 2019-09-02
- Last Changed: 2019-10-25
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-1917">FDA-2019-D-1917</a>

## Related Documents

- [QTc Information in Human Prescription Drug and Biological Product Labeling: Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/qtc-information-in-human-prescription-drug-and-biological-product-labeling-draft-guidance-for-industry/31125149-7d83-4062-9793-55cba93d1ee0)
- [Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/indications-and-usage-section-of-labeling-for-human-prescription-drug-and-biological-products-content-and-format-guidance-for-industry/7d286113-df13-47f4-bc30-1a4d819e56c9)
- [Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products](https://www.globalkeysolutions.net/guidances/guidance-document/considerations-for-the-design-and-conduct-of-externally-controlled-trials-for-drug-and-biological-products/9dafe0c9-19d4-48c0-a1ca-6b2a04a813ed)