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Expanded Access Navigator

Submitted by admin on Tue, 08/08/2017 - 15:22

The Expanded Access Navigator, or EA Navigator, represents a unique partnership between the Reagan-Udall Foundation for the FDA, patient advocacy organizations, the pharmaceutical industry, and the federal government to provide clear, digestible information on single-patient EA. This website provides a roadmap to guide patients, caregivers, and physicians through the request process, which involves various decisions, steps, and players, including pharmaceutical companies, the FDA, and Institutional Review Boards (IRBs). The Navigator clarifies the process for people who need information on investigational therapy or treatment options, which include clinical trials and EAPs, as well as single-patient EA. The goal of the Navigator is to increase understanding of the request process, not to encourage or discourage requests for expanded access.

It provides in one place information about the expanded access policies of various companies and the availability of investigational medicines under them. It also helps lead patients and physicians through the request process. The navigator currently focuses on cancer drug manufacturers and resources, but will gradually be expanded to include drugs for other diseases.

The Expanded Access Navigator is divided into two sections, one for patients and caregivers, the other for physicians.

  • The patient and caregiver section explains expanded access, helps users find appropriate clinical trials, and describes how to work with a physician to request access to an investigational medicine.
  • The physician section helps clinicians identify investigational treatment options for their patients, and walks them through the process of asking a pharmaceutical company about expanded access for a patient and submitting an expanded access form to the FDA. (The agency has taken steps to streamline the process for physicians, and last year introduced a shortened application form to simplify the necessary paperwork.)