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Expanded Access Programs and Pre-Approval Access

Expanded Access Programs and Pre-Approval Access

If a clinical trial is not available or right for you, there may be other options. Patients may sometimes obtain access to an investigational medicine through expanded access programs (EAP). EAPs provide a way for pharmaceutical companies to provide some investigational medicines to patients before the medicines have been approved by the government health authority in the country in which they live. EAPs also need to be approved by government health authorities.

In the United States, EAPs are only authorized by the U.S. FDA for:

  • patients with a serious or life-threatening disease or condition
  • patients with no comparable or satisfactory other treatment options available

In addition, there needs to be sufficient information to believe that the risks associated with a particular medicine are reasonable in light of the potential benefit.

Watch Dr. Amrit Ray discuss access to investigational medicines.

Generally we consider opening an EAP in the U.S. when our clinical studies are done and we are waiting for approval of our investigational medicine from government health authorities. However, an EAP is not opened for every investigational medicine. Our company does not offer EAPs when investigational medicines are in early testing because there are still too many unknowns. When an investigational medicine is first being tested in people, we are still learning which specific patients might benefit from the treatment and what types of side effects the medicine may cause. The list of Janssen EAPs can be found at www.clinicaltrials.gov.

This FDA form is what a treating physician would use to submit a compassionate use request on behalf of his/her patient. (In order to access Form FDA 3926, this link must be opened in Internet Explorer.)

For patients, not eligible for clinical trials or EAPs, compassionate use may be considered. Additional information is provided in the "How to Get More Information" section, or in this glossary. In addition, this article provides background knowledge on how to gain access to unapproved drugs and common misconceptions regarding approval.

This document summarizes our company’s approach for those seeking access to investigational medicines that have not yet been approved

Compassionate Use & Pre-Approval Access

Compassionate Use & Pre-Approval Access

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