Expanded Access (EA) or “compassionate use” is an FDA-regulated pathway allowing a patient to receive an investigational drug outside of a clinical trial. This may be an option if you have already exhausted your treatment options, are not eligible for a trial, or cannot participate in a clinical trial.
Read below to learn about Expanded Access Programs (EAPs), single-patient expanded access, as well as how to apply.
- Expanded Access: Information for Patients
- Expanded Access: Keywords, Definitions, and Resources
- Expanded Access Categories for Drugs (Including Biologics) Describes Expanded Access Programs (EAPs) and Single-Patient expanded access.
- Oncology Expanded Access Program Update (webinar)
Pharmaceutical Company Information
- Expanded Access & Compassionate Use (video) Pfizer explains what a pharmaceutical company looks for when reviewing an Expanded Access application.
How to Find Breast Cancer Expanded Access Drugs
- The Expanded Access Navigator The Reagan-Udall Foundation for the FDA provides free navigation information for finding breast cancer drugs available through the Expanded Access program.
How to Apply
- How to Submit a Request for Expanded Access The FDA’s library of forms and instructions for applying for Expanded Access.
- Submit an Application for Expanded Access From the Reagan-Udall Foundation for the FDA
Last Modified on March 14, 2021