New FDA Resource Helps Companies Manage Expanded Access Requests
The Reagan-Udall Foundation for the U.S. Food and Drug Administration has added a new guide for companies regarding use of the Expanded Access Navigator. This guide is intended to provide small and emerging biopharmaceutical companies with assistance in understanding the procedures for expanded access, developing an expanded access policy for their company, and responding to requests for single-patient expanded access.
All companies with drugs or biologics in clinical trials are required to have expanded access policies under the 21st Century Cures Act of 2016. This guide—which joins the Navigator's existing guides for patients and caregivers as well as for physicians—provides policy templates, essential information and resources on regulatory issues, and steers users through the intricacies of gaining access to investigational therapies through the expanded access program.