Lupus Patient-Focused Drug Development Meeting
Lupus Patient-Focused Drug Development Meeting

The Lupus Research Alliance collaborated with the Lupus and Allied Diseases Association and the Lupus Foundation of America on a groundbreaking initiative in cooperation with the Food and Drug Administration’s (FDA) externally-led Patient-Focused Drug Development (PFDD) program. The well-attended meeting hosted by the three groups supplemented by a national survey of people with lupus resulted in a comprehensive report, Lupus: Patient Voices, released this spring. With quantifiable results and personal accounts from people with lupus, the report has been shared with the FDA.

The information meets the FDA criteria for patient experience data, meaning that the findings can be considered during the Agency’s review and approval process of new drugs for lupus. The FDA initiated the PFDD program as part of its commitment to “systematically obtain the patient perspective on specific diseases and their treatments.”

Kenneth M. Farber, President and CEO of the Lupus Research Alliance, noted, “We are proud to have collaborated with the lupus community nationwide in supporting the FDA’s commitment to hearing patient concerns and priorities. This pioneering approach to providing the FDA with patient perspectives empowers patients with the knowledge that their words can open minds and guide policy.”

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