FDA Guide for Physicians for Obtaining Expanded Access

FDA has posted a guide for physicians seeking to submit requests for non-emergency single-patient expanded access to investigational therapies. According to the guide, such requests begin with a physician obtaining a Letter of Authorization (LOA) from the pharmaceutical company that makes the investigational drug. “A LOA grants the right of reference to the information contained in the supplier’s existing Investigational New Drug (IND) application,” it says. “If a LOA is not available, submit sufficient information for FDA to assure the product’s quality. A Letter of Authorization template is available from FDA.”

Next, physicians are advised to fill out Form FDA 3926 ( see instructions) and submit it with the LOA. IRB approval is also required, and informed consent should be obtained from the patient or their legally authorized representative.