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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.
Embargoed until 9 a.m. EDT June 3, 2019
Media Inquiries: Lea Ann Browning-McNee, 301-509-1846
Consumer/Provider Inquiries: 202-849-2075
Expanded Access Navigator Improves Patient Access to Investigational Therapies
New enhancements make it easier for patients, caregivers and healthcare providers to find crucial information
"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”
June Wasser Departs Reagan-Udall Foundation for the FDA
Amar Bhat, PhD, named Interim Executive Director
