FDA Drug Info Rounds Expanded Access Video Series
Welcome to the FDA Drug Info Rounds Expanded Access (EA) Video series. Expanded access is a program regulated by FDA through which manufacturers can provide investigational medical products to patients for treatment use. Expanded access can provide seriously ill patients with access to investigational treatments when they have no other options and they are willing to accept greater risk.
This series of videos provides an introduction to EA, instructions on submitting a single patient investigational new drug application, and tutorials on completing Form FDA 3926 for initial and follow-up submissions.
- Expanded Access Part 1: Introduction
An introduction to Expanded Access for investigational medical products
- Expanded Access Part 2: How to Submit a Single Patient IND
An overview on the submission process for emergency and non-emergency expanded access applications.
- Expanded Access Part 3: How to Complete Form FDA 3926 for Initial Submissions
Provides instructions on completing Form FDA 3926, a one-page form, front and back for initial submissions.
- Expanded Access Part 4: How to Complete Form FDA 3926 for Follow-up Submissions
Provides instructions on completing Form FDA 3926 for follow-up submissions.