FDA Streamlines Expanded Access for Oncology Agents

June 3, 2019 – The FDA has unveiled what it describes as a pilot “concierge service” for oncologists and patients seeking information and assistance with expanded access (EA) to investigational therapies. The two-pronged program is called Project Facilitate, run by the FDA Oncology Center of Excellence, and EA Navigator, which is operated by the Reagan-Udall Foundation for the FDA. Expanded access or “compassionate use” programs make investigational … (leggi tutto)