Mechanisms to Improve Awareness and Transparency of Expanded Access Processes and Programs; Public Workshop
This meeting will be held on May 16, 2016, in Silver Spring, MD, 8:30 a.m. to 11:45 a.m.
FDA White Oak Campus
Building 31, Great Room
10903 New Hampshire Avenue
Silver Spring, MD 20993
Goals and Objectives:
The Reagan-Udall Foundation for The Food and Drug Administration (RUF) is announcing a public workshop, co-hosted by the US FDA, to solicit feedback on a proposed Expanded Access Navigator. The Expanded Access Navigator would serve as a coordinated resource for clear information to help patients and healthcare providers navigate the Expanded Access (EA) request process, also known as compassionate use. The focus of the EA Navigator would be (non-emergency) individual patient access to investigational drugs (“single patient INDs”).
The purpose of this half-day workshop is for RUF to have an open discussion with interested stakeholders on the proposed functions of the EA Navigator and the challenges in the EA request process that it is intended to address. This workshop is part of a stakeholder consultation process designed to assess needs, evaluate potential solutions and determine feasibility of an EA Navigator. The workshop presents an opportunity to provide input on the design, necessity, and refinement of the EA Navigator.
Please note that the goal of the EA Navigator, and of this workshop, is to discuss how best to disseminate information on the EA request process. The EA Navigator would not provide treatment advice or information on treatments under investigation, nor would it impact decisions regarding eligibility and access to investigational drugs. Therefore, these topics will not be discussed at the workshop.
Who Should Attend:
This public workshop is intended for patients, patient advocacy groups, healthcare providers, drug manufacturers, Institutional Review Boards (IRBs), representatives from academia, and other interested persons.
There is no fee to attend this workshop, but attendees should register in advance. Space is limited and registration will be on a first-come, first-served basis. Persons interested in attending this workshop must register online here (via Eventbrite) before May 9, 2016.
For more information:
For more information, please visit http://www.reaganudall.org/news-and-events/events-2/public-workshop-expanded-access-navigator/.