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

Source: https://www.globalkeysolutions.net/guidances/guidance-document/expanded-access-to-investigational-drugs-for-treatment-use-questions-and-answers/c8db4f04-043a-440b-838b-50bc0e9b17c9

> FDA guidance document: Expanded Access to Investigational Drugs for Treatment Use:  Questions and Answers. Issue date: November 01, 2022. 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: 2022-11-01
- Comment Close Date: 2023-01-03
- Last Changed: 2023-05-18
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2013-D-0446">FDA-2013-D-0446</a>

## Related Documents

- [Drug Master Files Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/drug-master-files-guidance-for-industry/7dfd5140-3156-43f2-bdb9-d23ad597311c)
- [Accelerated Approval – Expedited Program for Serious Conditions](https://www.globalkeysolutions.net/guidances/guidance-document/accelerated-approval-expedited-program-for-serious-conditions/7bda38cb-af37-463c-93d1-9a573a6f6fc9)
- [Considerations for Rescinding Breakthrough Therapy Designation](https://www.globalkeysolutions.net/guidances/guidance-document/considerations-for-rescinding-breakthrough-therapy-designation/adc0ae37-722c-4b21-90ea-5a2087f771f0)