FDA streamlines process to request 'compassionate use' drugs for patients

The U.S. Food and Drug Administration Thursday finalized a streamlined process for physicians to request access to experimental drugs and biologics for their patients. The process for "compassionate use" now includes a shorter form that should take physicians about 45 minutes to complete. "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," said FDA commissioner Robert Califf, M.D. The FDA includes step-by-step instructions for filling out the form, as well as a question and answer about the process. FDA statement