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

Source: https://www.keypedia.com/guidances/guidance-document/expanded-access-to-investigational-drugs-for-treatment-use-questions-and-answers/9bb69e41-e105-4381-9ff7-898811ff1b7c

> FDA guidance document: Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers. Issue date: October 22, 2025. Get complete insights and analysis.

---

## 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: 2025-10-22
- Last Changed: 2025-11-14
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2013-D-0446">FDA-2013-D-0446</a>

## Related Documents

- [Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry:  Guidance for Industry](https://www.keypedia.com/guidances/guidance-document/expansion-cohorts-use-in-first-in-human-clinical-trials-to-expedite-development-of-oncology-drugs-and-biologics-guidance-for-industry-guidance-for-industry/c3a82e7e-71fa-4de1-a294-c42a2c2954cd)
- [Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers:  Guidance for Industry](https://www.keypedia.com/guidances/guidance-document/expanded-access-to-investigational-drugs-for-treatment-use-questions-and-answers-guidance-for-industry/12e2fbc0-e56f-4be2-8fa3-278d7a366326)
- [Charging for Investigational Drugs Under an IND: Questions and Answers](https://www.keypedia.com/guidances/guidance-document/charging-for-investigational-drugs-under-an-ind-questions-and-answers/e6ac16bc-3e90-4996-b2e5-b9671d33c720)