# Premarketing Risk Assessment:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/premarketing-risk-assessment-guidance-for-industry/232a7962-0cba-49be-a6b4-356c35b5f91f

> FDA guidance document: Premarketing Risk Assessment:  Guidance for Industry. Issue date: March 29, 2005. Get complete insights and analysis.

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## Details

- Title: Premarketing Risk Assessment:  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: 2005-03-29
- Last Changed: 2025-01-31
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2004-D-0121">FDA-2004-D-0121</a>

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