The nonprofit Reagan-Udall Foundation for the Food and Drug Administration has released a new, online resource called the Expanded Access Navigator. The website, which focuses on oncology with plans to expand to other disease areas, features the first pharmaceutical company directory of expanded access policies and criteria, as well as educational resources, guides and downloadable forms. ASCO was one of several organizations to help develop the Navigator.
The Navigator guides patients and physicians through the complicated process often called compassionate use, beginning with assessing whether all approved therapeutic options for patients with serious or life-threatening conditions are exhausted. If no clinical trials or expanded access programs are available or accessible, the Navigator acts as a clearinghouse for the single-patient expanded access policies of dozens of leading biopharmaceutical companies.
ASCO, the American Cancer Society, the Biotechnology Industry Association, FDA, Foundation Medicine, PhRMA and Susan G. Komen helped develop the Navigator along with the support of Bristol-Meyers Squibb, Genentech, Janssen, Lilly, Merck and Pfizer.
To access the Navigator, go to: http://navigator.reaganudall.org/.