Clinical Development Programs for Disease-Modifying Agents for Peripheral Neuropathy: Public Workshop; Request for Comments
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) is announcing a scientific workshop to solicit information on a variety of issues related to the clinical development of disease-modifying agents for the treatment of peripheral neuropathy. Discussion will focus on possible therapeutic targets for these agents, the types of painful peripheral neuropathies amenable to treatment with disease-modifying agents, and clinical trial design. FDA intends to take this information into account in order to develop FDA guidance on clinical development programs for disease-modifying products for the management of peripheral neuropathy.
Date(s): February 11, 2013 from 8:30 a.m. to 5:30 p.m. and February 12, 2013 from 8:30 a.m. to 1:00 p.m.
Location: FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Conference Center, The Great Room, (Rm 1503)
Silver Spring, MD 20993
Registration: If you wish to attend the workshop or provide oral comments during the open session of the meeting, please email your registration to CDER_Neuropathy_Workshop@fda.hhs.gov by Februrary 1, 2013.
Webinar of the Meeting
- Opening Remarks – Smith Presentation (https://collaboration.fda.gov/p95902438/)
- Panel 1 Discussion – Wolfe Presentation (https://collaboration.fda.gov/p76799527/)
- Open Public Hearing –Panel 2 Discussion (https://collaboration.fda.gov/p86417154/)
- Panel 3 Introduction - Adjournment (https://collaboration.fda.gov/p18979410/)
- Opening Remarks – Panel 4 Discussion (https://collaboration.fda.gov/p40217733/)
- Panel 5 Introduction – Adjournment (https://collaboration.fda.gov/p80687513/)
Presentations – Day 1
Marc Walton, MD, PhD(PDF - 351KB) Vera Bril, MD(PDF - 2.2MB) Aaron Vinik, MD, PhD, FCP, MACP(PDF - 3.2MB) A. Gordon Smith, MD(PDF - 2.3MB) Eva Feldman, MD, PhD, FAAN(PDF - 123KB) Gil Wolfe, MD(PDF - 2.7MB) Joseph Arezzo, PhD(PDF - 639KB)
- Prof. Dan Ziegler, FRCPE (PDF - 1.3MB)
James Russell, MD, MS, FRCP, FACP(PDF - 1.4MB) Open Public Hearing: Rudolf Guthoff(PDF - 7.1MB) Rayaz Malik, MD(PDF - 2.2MB) Michael Polydefkis, MD, MHS(PDF - 5.8MB)