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

Source: https://www.globalkeysolutions.net/guidances/guidance-document/expanded-access-to-investigational-drugs-for-treatment-use-questions-and-answers-guidance-for-industry/12e2fbc0-e56f-4be2-8fa3-278d7a366326

> FDA guidance document: Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers:  Guidance for Industry. Issue date: June 03, 2016. Get complete insights and analysis.

---

## Details

- Title: Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers:  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: 2016-06-03
- Last Changed: 2022-11-15
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2013-D-0446">FDA-2013-D-0446</a>

## Related Documents

- [Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers](https://www.globalkeysolutions.net/guidances/guidance-document/expanded-access-to-investigational-drugs-for-treatment-use-questions-and-answers/9bb69e41-e105-4381-9ff7-898811ff1b7c)
- [M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/m4-organization-of-the-common-technical-document-for-the-registration-of-pharmaceuticals-for-human-use-guidance-for-industry/e5a79d19-73aa-4d4c-baa8-342b5ddc7632)
- [E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers](https://www.globalkeysolutions.net/guidances/guidance-document/e2cr2-periodic-benefit-risk-evaluation-report-questions-and-answers/9735c0c5-468e-4e9b-a4c9-a7bad1eb9d94)