The FDA’s expanded access program has allowed many desperately ill patients to receive experimental treatments in an effort to save lives. Just last fiscal year, over 1,700 requests were made by patients to access experimental treatments. The Food and Drug Administration’s Center for Drug Evaluation and Research and their Center for Biologics Evaluation and Research combined approved 99.4% of those requests. http://bit.ly/2f61bvK
- Can expanded access give insight into the future success or failure of a new treatment?
- How could research of stem cells improve the delivery of cancer drugs to metastatic tumors?
- Could wider inclusion of minority patients in clinical trials actually lower the cost of healthcare overall?
- New Waiver in IRB Process Speeds FDA Single Patient Expanded Access Approval; Updated Information available on WCGF website.
- How could a new treatment, given previously under expanded access, successfully treat a serious disease of the eye?