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

• Federal Register Notice
• Agenda (PDF - 29KB)

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

Day 1:

• 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/)

Day 2:

• Opening Remarks – Panel 4 Discussion (https://collaboration.fda.gov/p40217733/)
• Panel 5 Introduction – Adjournment (https://collaboration.fda.gov/p80687513/)