In 1988, the U.S. Food and Drug Administration (FDA) published a final rule, Annual Summary Reporting Requirements Under the Right to Try Act, which specifies the deadline and content for annual reports by sponsors or manufacturers who provide an eligible investigational drug under the Right to Try Act.

The Right to Try Act is one way for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain investigational treatment options. FDA’s role in implementing the Right to Try Act is limited to receiving and posting certain information submitted to the agency.

A manufacturer or sponsor of a CDER-regulated drug or biological product provided under the Right to Try Act  should submit their annual summary through the CDER NextGen Portal (the Portal). Manufacturers or sponsors should continue to use Form FDA 5023, which should be uploaded as part of their submission to the Portal.

Manufacturers or sponsors will have to register and sign into the Portal before submitting the Right to Try submission. The CDER NextGen Portal Registration Instructions Video and FDA Alternate Submission for Right to Try Quick Reference Guide will be accessible after registering and signing into the Portal.

For patients with serious or immediately life-threatening diseases or conditions, FDA remains committed to enhancing access to promising investigational medicines for those unable to access investigational medical products through clinical trials.