# Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/content-and-format-of-investigational-new-drug-applications-inds-for-phase-1-studies-of-drugs-including-well-characterized-therapeutic-biotechnology-derived-products-guidance-for-industry/ecc5878c-4062-49df-90cc-6ac91b3adb4c

> FDA guidance document: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products:  Guidance for Industry. Issue date: November 01, 1995. Get complete insights and analysis.

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## Details

- Title: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products:  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: 1995-11-01
- Last Changed: 2020-05-06
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1995-D-0251">FDA-1995-D-0251</a>

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