# Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/patient-counseling-information-section-of-labeling-for-human-prescription-drug-and-biological-products-content-and-format/91c267ae-e99d-4508-b31c-721b7da25d2b

> FDA guidance document: Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format. Issue date: December 10, 2014. Get complete insights and analysis.

---

## Details

- Title: Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2014-12-10
- Last Changed: 2020-04-27
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2013-D-1067">FDA-2013-D-1067</a>

## Related Documents

- [Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format](https://www.globalkeysolutions.net/guidances/guidance-document/clinical-pharmacology-labeling-for-human-prescription-drug-and-biological-products-content-and-format/43229708-ad02-40d3-b318-996c20552a39)
- [Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format](https://www.globalkeysolutions.net/guidances/guidance-document/instructions-for-use-patient-labeling-for-human-prescription-drug-and-biological-products-content-and-format/6292a71a-45d3-4698-bff7-3fab3969aacb)
- [Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act](https://www.globalkeysolutions.net/guidances/guidance-document/providing-regulatory-submissions-in-electronic-format-submissions-under-section-745aa-of-the-federal-food-drug-and-cosmetic-act/e05964dd-2751-4636-8630-94e3ed036135)