FDA Simplifies Process for Requesting Expanded Access to Investigational Drugs


On Thursday, June 2nd FDA released the final Individual Patient Expanded Access Investigational New Drug Application (Form FDA 3926), which is a new form for physicians to use when requesting expanded access to investigational drugs and biologics for their patients.

FDA’s expanded access program, also referred to as “compassionate use,” allows patients with serious or immediately life-threatening diseases to be able to access investigational treatments.  According to its recent press release, FDA states that “access to investigational treatments requires the active cooperation of the FDA, industry, and health care professionals in order to be successful.”  As such, the Agency also states that it understands the importance of patients being able to access these treatments, and it is committed to streamlining the process and “reducing the procedural burdens on physicians and patients whenever possible.”

FDA’s new form will help physicians by reducing the amount of time spent filling out a request for access to an investigational drug.  In fact, FDA claims that the new form should only take physicians about 45 minutes to complete.  In an attempt to make the request process as straightforward as possible, the FDA has also released step-by-step instructions on how to complete this new form.

In addition to its new form, the FDA also published two final guidance documents on June 2nd.  “One is in a question and answer format and explains what expand access is, when and how to request expanded access, and the type of information that should be included in requests. The other explains the regulations regarding how patients may be charged for investigational drugs.”

Are you interested in learning more about the FDA’s recent draft guidances regarding expanded access to investigational drugs?  Stay tuned, more information on each document is coming soon.

Are you seeking approval of a compassionate use request?  We can help with this or any other type of FDA submission.  To learn more about our services and how we can help you obtain FDA approval, contact us today.