# Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers – FDA Guidance

Source: https://www.keypedia.com/guidances/guidance-document/expanded-access-to-investigational-drugs-for-treatment-use-questions-and-answers/40eaf0fa-a852-4796-a330-c72e8bce14e2

> FDA guidance document: Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers. Issue date: April 15, 2026. Get complete insights and analysis.

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## Details

- Title: Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
- 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: 2026-04-15
- Last Changed: 2026-04-17
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2013-D-0446">FDA-2013-D-0446</a>

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