FDA Finalizes Three Guidances on Expanded Access to Investigational Drugs

Hand holding red pills and white pill bottle

Expanded access is the process by which investigational treatment options are made available to patients with serious and/or life-threatening diseases or conditions who lack therapeutic alternatives. These guidances provide greater clarity about the expanded access process and will allow healthcare providers to more easily navigate the expanded access process and thus enable patients who qualify to access potentially life-saving medications ore readily.

The first guidance, “Individual Patient Expanded Access Applications: Form FDA 3926,” describes the process for a licensed physician to request use of an investigational drug to treat an individual patient who has no other treatment options.

The second guidance, “Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers,” explores frequently asked questions related to the implementation of the FDA regulations on expanded access to investigational drugs.

The third guidance, “Charging for Investigational Drugs Under an IND – Questions and Answers,” addresses questions related to the charging for investigational drugs under an IND in the context of clinical trials or expanded access for treatment use.

Patient and Physician fact sheets have been developed by the FDA and can be found on their website. The FDA will host a webinar on July 12 at 1:00 pm to explain the expanded access process and the new Individual Patient Expanded Access Application.