# Monoclonal Antibodies: Streamlined Nonclinical Safety Studies: Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/monoclonal-antibodies-streamlined-nonclinical-safety-studies-draft-guidance-for-industry/439cec36-0e7d-4c02-88e4-7a0af7b47fa4

> FDA guidance document: Monoclonal Antibodies: Streamlined Nonclinical Safety Studies: Draft Guidance for Industry. Issue date: December 02, 2025. Get complete insights and analysis.

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## Details

- Title: Monoclonal Antibodies: Streamlined Nonclinical Safety Studies: Draft Guidance for Industry
- 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: 2025-12-02
- Last Changed: 2025-12-02
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2025-D-4634">FDA-2025-D-4634</a>

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