# Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format - FDA Guidance Document Source: 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 > FDA guidance document: Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format. Issue date: December 05, 2016. Get complete insights and analysis. --- ## Details - Title: Clinical Pharmacology 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: 2016-12-05 - Last Changed: 2020-05-07 - Docket Number: FDA-2009-D-0095 ## Related Documents - [General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/general-clinical-pharmacology-considerations-for-neonatal-studies-for-drugs-and-biological-products-guidance-for-industry/0c57731e-55bc-4962-a619-54444aa22335) - [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) - [Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format](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)