# Data Standards for Drug and Biological Product Submissions Containing Real-World Data:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/data-standards-for-drug-and-biological-product-submissions-containing-real-world-data-guidance-for-industry/7cd29686-06b7-467b-bad3-2023b48076b2

> FDA guidance document: Data Standards for Drug and Biological Product Submissions Containing Real-World Data:  Guidance for Industry. Issue date: December 21, 2023. Get complete insights and analysis.

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## Details

- Title: Data Standards for Drug and Biological Product Submissions Containing Real-World Data:  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: 2023-12-21
- Comment Close Date: 2022-01-21
- Last Changed: 2025-01-31
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2021-D-0548">FDA-2021-D-0548</a>

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