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Apr. 28, 2015

TOPIC: Advocacy

FDA Public Meeting on Chagas Disease Patient-Focused Drug Development

Posted by Jennifer Huron

FDAPaul Melmeyer, NORD’s Assistant Director of Public Policy, attended the FDA’s public meeting on Chagas Disease Patient-Focused Drug Development on April 28.  Chagas is a rare parasitic disease (read NORD’s Rare Disease Report here) that is spread by insects.  While it is quite rare in the U.S., it greatly afflicts central and south American (~20 million patients).

Melmeyer said, “The latest Patient-Focused Drug Development meeting on Chagas Disease was yet another excellent opportunity for patients with a neglected disease to interact with FDA officials. Through the course of the meeting, patients and physicians who previously felt their voice was not heard were able to educate the FDA and the audience about this little known devastating infectious disease. It was a privilege to be in attendance.”

The event served as an opportunity for the FDA to provide information for and gain perspective patients and patient advocacy organizations, health care providers, academic experts, and industry on various aspects of clinical development of drug products intended to treat Chagas disease.  Opening remarks were provided by John Farley, MD, MPH Deputy Director, Office of Antimicrobial Products at the FDA.  Other invited speakers addressed review considerations for new drugs in the U.S. and recent, ongoing, and planned clinical trials for Chagas.

Individuals can submit written comments to the docket through June 29, 2015.

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