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.
Because the effectiveness (how well the drug works) and risks of using investigational drugs are unknown, the Expanded Access pathway requires a treating physician to apply on behalf of their patient. The full application process also involves the FDA, the IRB (Institutional Review Board), and the pharmaceutical company that makes the investigational drug.
Read below to learn about Expanded Access Programs (EAPs), single-patient expanded access, as well as how to apply.
FDA Publications
- 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