# General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry - FDA Guidance Document

Source: 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

> FDA guidance document: General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry. Issue date: July 27, 2022. Get complete insights and analysis.

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## Details

- Title: General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products 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: 2022-07-27
- Last Changed: 2024-04-15
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-3132">FDA-2019-D-3132</a>

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