The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.
FDA today released a new FDA Voice Blog: The Expanded Access Navigator – Helping Patients In Need of Potentially Life-Saving Drug Treatments, that provides details about a new tool the Reagan-Udall Foundation developed for patients, caregivers and their physicians who are seeking single-patient expanded access. Expanded access is reserved for 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. Now, there is another option to guide them through the process with 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.
For more information, please visit: The FDA Voice Blog - Expanded Access Navigator.