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  4. Project Facilitate & EA Navigator: FDA OCE and Reagan-Udall Foundation: Working Together to Enable Patient Access to Investigational Oncology Drugs - 05/16/2019 - 05/16/2019
  1. FDA Meetings, Conferences and Workshops

Workshop | In Person

Event Title
Project Facilitate & EA Navigator: FDA OCE and Reagan-Udall Foundation: Working Together to Enable Patient Access to Investigational Oncology Drugs
May 16, 2019

Date:
May 16, 2019
Location:
Event Location
White Oak Campus: The Great Room
Conference Center

10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States


Organized By:
Organizer

Twitter: #ProjectFacilitate

Background:

The FDA is convening this public workshop to discuss Project Facilitate, a pilot program developed under the Oncology Center of Excellence (OCE). Project Facilitate is planned as a call center to facilitate the Single Patient IND request process for oncologists treating patients with cancer.

Workshop Objectives:

  • Obtain input from multiple stakeholders on gaps in patient and healthcare provider knowledge of the current system for Single Patient IND requests, challenges with the current system for requesting Single Patient INDs, and suggestions for improving the current system.
  • Discuss updates to Reagan-Udall Foundation’s Expanded Access Navigator.
  • Obtain feedback on Project Facilitate, a planned pilot call center to facilitate the Single Patient IND request process for oncologists treating patients with cancer

Webcast Information:

FDA provided a free-of-charge, live webcast of this workshop.

Recordings of the webcast can be found at the following link:

 Meeting Information:

Contact:

Dianne Spillman
Dianne.Spillman@fda.hhs.gov
(301) 796-1467

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