# Clinical Studies 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/clinical-studies-section-of-labeling-for-human-prescription-drug-and-biological-products-content-and-format-guidance-for-industry/8675c759-b657-4818-9bed-199de1148828 > FDA guidance document: Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format: Guidance for Industry. Issue date: January 24, 2006. Get complete insights and analysis. --- ## Details - Title: Clinical Studies 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: 2006-01-24 - Last Changed: 2025-01-31 - Docket Number: FDA-2000-D-0074 ## Related Documents - [Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format](https://www.globalkeysolutions.net/guidances/guidance-document/adverse-reactions-section-of-labeling-for-human-prescription-drug-and-biological-products-content-and-format/ce6d5ce5-74d1-4dfa-b9e2-2231be5d58c1) - [IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer: Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/ind-exemptions-for-studies-of-lawfully-marketed-drug-or-biological-products-for-the-treatment-of-cancer-guidance-for-industry/fa85146f-e37f-41a7-a38d-60e7f38b337d) - [S8 Immunotoxicity Studies for Human Pharmaceuticals](https://www.globalkeysolutions.net/guidances/guidance-document/s8-immunotoxicity-studies-for-human-pharmaceuticals/216b9605-e0e0-4dd4-a10b-a51326a268f5)