# General Considerations for the Use of New Approach Methodologies in Drug Development: Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/general-considerations-for-the-use-of-new-approach-methodologies-in-drug-development-draft-guidance-for-industry/090afb3a-8fce-4ac8-ac78-d208784d28ff

> FDA guidance document: General Considerations for the Use of New Approach Methodologies in Drug Development: Draft Guidance for Industry. Issue date: March 18, 2026. Get complete insights and analysis.

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## Details

- Title: General Considerations for the Use of New Approach Methodologies in Drug Development: Draft Guidance for Industry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: 2026-03-18
- Last Changed: 2026-03-18
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2025-D-6131">FDA-2025-D-6131</a>

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