Daily Rules, Proposed Rules, and Notices of the Federal Government
For those interested in providing oral comments for the open public hearing, please also provide a short abstract of your remarks by February 1, 2013. We will try to accommodate all persons who wish to speak; however, the duration of each speaker's comments during this open public hearing may be limited by time constraints.
Registration is free and will be on a first-come, first-served basis. Early registration is recommended because seating is limited. FDA may limit the number of participants from each organization as well as the total number of participants based on space limitations. Registrants will receive confirmation once they have been accepted for the workshop. Onsite registration on the day of the meeting will be based on space availability. If registration reaches maximum capacity, FDA will post a notice closing meeting registration for the workshop at
If you need special accommodations because of a disability, please contact Randi Clark or Allison Meyer (see
FDA is announcing this public workshop to further the understanding of the development of disease-modifying agents for the treatment of painful peripheral neuropathies. 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 will explore the following topics during this public workshop:
1. Pharmacodynamic mechanisms and pharmacogenetic/pharmacogenomic targets of therapeutic agents intended to prevent, slow, modify, arrest, or reverse the course of disease for peripheral neuropathies.
2. Periperal neuropathy patient populations and study entry criteria for clinical trials designed to evaluate disease-modifying effects of therapeutic agents.
3. Clinically relevant endpoints for trials evaluating therapeutic agents intended to prevent, slow, modify, arrest, or reverse the course of these diseases.
4. Study duration, overall study design, and analysis of clinical trials needed to demonstrate a treatment effect on disease modification for peripheral neuropathy.
FDA will post the agenda and additional workshop background material approximately 5 days before the workshop at
Please be advised that as soon as a transcript is available, it will be accessible at