Today, FDA issued three final guidances for industry related to expanded access. Expanded access is FDA’s process to facilitate the availability of investigational treatment options to patients with serious or immediately life-threatening diseases or conditions who lack therapeutic alternatives.
The first guidance, “Individual Patient Expanded Access Applications: Form FDA 3926” describes a streamlined option for licensed physicians to request use of an investigational new drug to treat individual patients who have exhausted other treatment options, including for emergency use. When Form FDA 3926 is substituted for the current Forms FDA 1571 and 1572, the agency estimates that each submission will take only 45 minutes, resulting in a significant burden reduction. Based on comments received from the public, the new form can also be used for follow-up submissions.
These steps to simplify and provide clarity about expanded access will help health care professionals, patients and industry to more easily navigate the expanded access process and enable patients who qualify to access potentially life-saving medications more readily.
FDA also developed
patient and
physician fact sheets to further inform stakeholders about expanded access and has revamped its website to make it more user-friendly.
FDA will also host a webinar for health care professionals on July 12, 2016 at 1:00 PM which will explain FDA’s expanded access process and the new Individual Patient Expanded Access Application. FDA will update stakeholders with details when available.
from FDA