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Neuropathy Association Participates in FDA Workshop on Advancing Neuropathy Clinical Research Trials

March 1, 2013


To view the
webcast from the
workshop and to
read the PowerPoint
slides, click here.


The Neuropathy Association recently participated in the first-ever scientific workshop hosted by the Food and Drug Administration (FDA) and the Center for Drug Evaluation and Research (CDER) in Silver Spring, Maryland last month. 

The goal of the workshop was to jump-start neuropathy research by targeting mechanisms causing the disease, not just therapies to treat symptoms—and, then, to accelerate those projects through the research and development pipeline to reach patients. 

The workshop’s panels included members from the Association’s Medical Advisory Committees, and Neuropathy Centers of Excellence, as well as medical advisor to the Association Dr. Thomas H. Brannagan, III. The Association's president and CEO Tina Tockarshewsky and Manhattan support group co-leader Michael Walter were asked to speak about the needs of neuropathy patients when participating in clinical trials.

Tockarshewsky shared with workshop participants, “Our neuropathy patients want to actively partner in and promote the research process—but, since research takes time, don’t leave us hanging without adequate treatments until the cures we need are found."

A stark reality acknowledged at the workshop was the need for funding—Federal, corporate, and private—to drive momentum forward. The FDA intends to take the information presented into account to develop FDA guidance on clinical development programs for disease-modifying products for the management of peripheral neuropathy.

 

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