The U.S. Food and Drug Administration (FDA) recently released a new form and guidance documents for physicians requesting individual expanded access for, or compassionate use of, investigational drugs and biologics.
“As a physician, I understand the importance of being able to access investigational treatments for a patient when there are no other options to treat their serious disease or condition,” FDA Commissioner Robert Califf said. “Access to investigational treatments requires the active cooperation of the FDA, industry and health care professionals in order to be successful. But we know that navigating that process can be challenging and time consuming, and we are committed to reducing the procedural burdens on physicians and patients whenever possible.”
The FDA updates to the process include a new, shorter form to request expanded access, Form FDA 3926, which should take physicians approximately 45 minutes to fill out. The administration also released a guide to completing the form, a frequently-asked-questions document on expanded access and a document explaining how physicians should charge patients for investigational drugs.
“The FDA has a long history of supporting patient access to investigational treatments, and we hope the information released today will help health care professionals, patients and industry to more easily navigate the expanded access process and help patients who qualify to gain access to potentially life-saving investigational treatments,” Califf said.