US FDA Blog: “Patients with serious or immediately life-threatening diseases or conditions who have no comparable or satisfactory alternative therapy and who seek access to potentially life-saving investigational drugs will have another option to guide them through the process – thanks to the launch today of a new online tool called the Expanded Access Navigator. The development of the Navigator was a team effort led by the Reagan-Udall Foundation in collaboration with patient advocacy groups, the pharmaceutical industry, FDA, and others in the Federal government. When a patient has a serious or immediately life-threatening disease or condition for which there is no FDA-approved treatment, they may be able to gain access to an investigational drug under the FDA Expanded Access process. Expanded Access permits the product’s manufacturer, with the authorization of FDA, to provide an investigational drug for a patient, even though the drug is still in development or under review for FDA approval. Each year FDA receives more than 1,000 applications requesting authorization of expanded access through individual patient, intermediate or large-size expanded access programs. FDA has worked to streamline the process, particularly with a simplified application for individual patient expanded access; however, it can still be challenging and time-consuming for patients, family members, caregivers, and health care professionals to navigate the system…”