FDA Takes Steps to Simplify Compassionate Use Process, Invites Comment


Get Permission

The U.S. Food and Drug Administration (FDA) introduced a more streamlined form for requesting permission for patient access to investigational drugs outside of clinical trials.

The new form is available for comment in a draft guidance for industry entitled “Individual Patient Expanded Access Applications: Form FDA 3926.” This draft guidance introduces and describes draft Form FDA 3926: Individual Patient Expanded Access-Investigational New Drug Application (IND). When finalized, the form will be available for physicians to use for expanded access requests for individual patient INDs. 

In a post on the FDA Voice Blog, Peter Lurie, MD, MPH, Associate FDA Commissioner for Public Health Strategy and Analysis, wrote that the agency developed the new form in response to concerns from physicians and patients that the current form was too difficult. It required 26 types of information and seven attachments, taking physicians about 100 hours to fill out. The new form requires only eight elements of information and a single attachment, and should take physicians about 45 minutes to complete. ■



Advertisement

Advertisement



Advertisement