Public Workshop: Expanded Access Navigator – May 16, 2016

RUF Public Workshop- Developing an Expanded Access Navigator for Individual Patient Access to Investigational Drugs

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.

Date:
May 16, 2016

Time:
8:30 a.m. to 11:45 a.m.

Location:
FDA White Oak Campus
Building 31, Great Room
10903 New Hampshire Ave
Silver Spring, MD 20993
For directions and parking, see: Public Meetings at the FDA White Oak Campus

Registration:
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. Onsite registration will be available if space permits. The agenda and additional background information can be found in the Workshop Materials section below.

Webcast:
If you are unable to attend in person and would like to follow the meeting live, we will be broadcasting the workshop in its entirety via a webcast. Please register  here (via Eventbrite).

View the recordings here:

Webcast Part 1:

  • Opening Remarks
  • Presentations on Expanded Access Request Process
  • Panel Discussion on the Proposed Expanded Access Navigator

Webcast Part 2:

  • Public Comments on the Proposed Expanded Access Navigator
  • Closing Remarks

We want your feedback!Form Image

Have feedback on the proposed Expanded Access Navigator? We want to hear from you. Please share your comments  with us to help improve and inform this proposed program. Comments can be submitted here. Deadline for comments is Friday, June 17, 2016.

 

Workshop Materials:

For questions regarding the workshop please contact:
Nancy Beck, Ph.D.
Acting Deputy Director
Reagan-Udall Foundation for the FDA
Email: nbeck@reaganudall.org