Jun. 01, 2016

Lupus Groups to Host Patient-Focused Drug Development Meeting

Today, the Alliance for Lupus Research (ALR), the Lupus and Allied Diseases Association (LADA), Lupus Foundation of America (LFA), and the Lupus Research Institute (LRI) announces that a Lupus Patient-Focused Drug Development Meeting - Lupus: Patient Voices - will be held in spring 2017.

This groundbreaking initiative will culminate in a meeting featuring a series of facilitated panel discussions designed to provide the Food and Drug Administration (FDA) with perspectives from people with lupus, advocates and caregivers. Following the successful model FDA developed to host similar meetings , the day will focus primarily on a range of patient viewpoints on lupus; covering the symptoms and impacts to daily life that are most important to people with lupus, as well as their perspective on existing and future treatments. This input can help inform the FDA’s decisions and oversight during drug development and the review of a marketing application for a new drug.

The four lupus organizations answered FDA’s call for groups to submit a Letter of Intent (LOI) to the FDA requesting to host an externally-led Patient Focused Drug Development (PFDD) meeting. The FDA recently accepted the LOI for lupus. This meeting will give the lupus community an opportunity to share insights that have the potential to be helpful to the process of developing new treatments for the disease.

This fall, the organizations will begin to gather input from people with lupus across the country through surveys and personal stories. At that time, information on how to participate will be made widely available throughout the national lupus community.

For more information about the Externally-Led PFDD Initiative Meetings, visit FDA.gov.


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