Individual (Single) Patients

Individual (Single) Patients2018-08-19T09:52:28+00:00

Individual (Single) Patients

Individual (single) patients who are desperately ill and have exhausted all other treatment options can request permission to try investigational (unapproved) products through two different pathways:

  • Food and Drug Administration (FDA) expanded access, which is available to patients who are seriously ill or have life-threatening conditions. This process includes reviews by both FDA and an institutional review board (IRB) to help ensure that the investigational product does not expose the patient to undue risks. FDA usually completes its review within a few days. From 2010 through 2015, FDA approved 99 percent of individual (single) patient requests for expanded access.
  • Right-to-Try, a new pathway made possible this year with the passage of federal right-to-try legislation. This pathway is available only to patients with life-threatening conditions. It does not require FDA or IRB review and, therefore, does not provide the resulting extra level of protection for patients.

Under both pathways, the request must be made by a licensed physician on behalf of the patient. Also under both pathways, the product manufacturer is not required to grant the request.

Clinical Research Pathways assists patients, treating physicians, and IRBs with the expanded access process. We provide comprehensive information to help you understand and navigate expanded access:

Additional Resources

From Clinical Research Pathways

FDA Expanded Access