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
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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
May 16, 2019 | 1:00 PM to 3:30 PM
FDA White Oak Campus Building 31, Room 1503 - Great Room
10903 New Hampshire Avenue, Silver Spring, MD 20993
Reagan-Udall Foundation for the Food and Drug Administration is seeking nominations through June 14, 2019, for its third annual Innovations in Regulatory Science Awards. These Awards honor outstanding achievements of individuals and organizations that have made distinguished contributions to regulatory science and policy.
Award Categories
The Awards will be presented in three categories this year. Full criteria is detailed in the nomination form (download below).
