For Patients

Learn About Expanded Access and Other Treatment Options

When a patient does not respond to current approved treatments for a variety of reasons, other options still may be available. For serious and life-threatening illnesses, some patients may want to talk to their healthcare provider about trying an investigational drug either through a clinical trial or expanded access, or trying an approved drug that is used for a different purpose than what is listed on the FDA-approved drug label (this use is called off-label).

Understanding Investigational Drugs and Off Label Use of Approved Drugs

Understanding Unapproved Use of Approved Drugs "Off-Label"

Has your healthcare provider ever talked to you about using a drug to treat your disease or medical condition that has not been studied on patients with your disease? It maybe helpful for you to understand what "Off-Label" use means and the questions you may need to ask your healthcare provider.

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Understanding Investigational Drugs and Off Label Use of Approved Drugs

Understanding Investigational Drugs

Has your healthcare provider ever talked to you about using an investigational drug to treat your disease or medical condition. It maybe helpful for you to understand what an investigational drug is before deciding if one might be right for you. Learn the basics of what they are and how you can get access.

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Understand-Expanded-Access

Understanding Expanded Access (Compassionate Use)

Information about FDA's current expanded access policies, requirements for enrolling in expanded access programs, and steps you can take to get more information.

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Page Last Updated: 05/31/2016
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