The Food and Drug Administration (FDA) announced the release of the final individual patient expanded access form (“compassionate use”) for physicians to use when requesting investigational drugs and biologics for their patients.
Physicians can use this new form to request access to investigational drugs for patients who have serious or immediately life-threatening diseases and for whom no comparable or satisfactory alternative therapy is available. The new form is shorter than the previous version used for compassionate use requests and is estimated to take 45 minutes to complete.
The FDA is issuing instructions on how to complete the form as well as two final guidance documents to further clarify the expanded access process: a question and answer document describing the required content of the form and a regulations document describing how patients may be charged for investigational drugs.
FDA Commissioner Robert Califf, MD, stated, “The FDA has a long history of supporting patient access to investigational treatments and we hope the information released today will help healthcare 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.”
The Individual Patient Expanded Access Investigational New Drug Application – Form FDA 3926 can be found here.
For more information call (888) 463-6332 or visit FDA.gov.