"A new initiative called the COVID-19 Evidence Accelerator aims to pool ongoing data sources from government and academic researchers, health systems, and private companies to solut
"Patients with cancer are treated with drugs already approved by the U.S. Food and Drug Administration (FDA) or with an investigational agent in a clinical trial. But there are some patients who may need access to investigational drugs outside the realm of a clinical trial..."
Read more about how Project Faciliate and the Foundation are working together to simplify the expanded access process: http://obroncology.com/article/fda-eases-access-to-unapproved-cancer-drugs/
The U.S. Food and Drug Administration (FDA) plans to provide oncologists with greater help in acquiring expanded access to investigational therapies. Deemed Project Facilitate, the pilot program was announced at a press briefing during the 2019 ASCO Annual Meeting.
Project Facilitate is essentially a call center that will be run by the FDA Oncology Center of Excellence. It’s a single point of contact where FDA oncology staff will help oncology providers submit an expanded access request for an individual patient.
The US Food and Drug Administration (FDA) on Monday launched a new pilot program, dubbed Project Facilitate, aimed at helping physicians complete expanded access requests for cancer patients.
FDA's Oncology Center of Excellence and the Reagan-Udall Foundation launched Expanded Access Navigator and Project Facilitate, two separate but coordinated pilot programs to provide patients and physicians with expanded access to oncology drugs. The launches came Monday at the American Society of Clinical Oncology (ASCO) meeting in Chicago.
"Sharpless said FDA's organization also must ensure collaboration across disciplines and locations, as well as with outside groups. In a speech to the Reagan-Udall Foundation annual meeting later in the day, though, he acknowledged that outside collaborations are often challenging for FDA."
Read Zach Brennan’s reference to the Foundation's Annual Public Meeting in his Regulatory Focus™ article: “Sharpless Begins to Learn the Ropes While FDA Center Directors Look to the Future”
New Drug Safety Priorities Report for 2018 highlights CDER’s safety work with a reference to our IMEDS program that "allows public and private entities access to the Sentinel System.”
Biocentury coverage on the FDA’s expanded access program and collaboration with the Reagan-Udall Foundation is available here: https://www.biocentury.com/biocentury/regulation/2018-12-14/how-fda-plans-help-patients-get-expanded-access-unapproved-drugs
Read The FDA Sentinel Initiative—An Evolving National Resource pubished in New England Journal of Medicine in November 2018 by Platt et al featuring our IMEDS program.
