Each year, the FDA receives over 1,000 applications for the treatment of patients through expanded access, also known as compassionate use. Prior to treating a patient under expanded access, the physician must obtain approval from the Institutional Review Board (IRB) at their facility. As part of a plan to simplify the process for physicians seeking access to an investigational product to treat their patient, the FDA has announced that just one IRB member – the chair or another appropriate person – can now approve the treatment. Click here to review the FDA announcement from Dr. Scott Gottleib released on October 3, 2017.
Please note: The updated submission form to the FDA will have a specific selection to make when you are requesting approval by an appropriate IRB member, this box must be checked with your FDA application and your submission to the IRB must confirm your selection of this option.
The IRB is working to update our submission guidance and requirements to align with this new flexibility. Feel free to contact an IRB director in advance of submitting any requests for expanded access/compassionate use if you have questions about the process or timeline for approval.