Lipodystrophy United Is Back! Please frequently visit our website to see updates!
What is an EL-PFDD?
Patient-Focused Drug Development (PFDD) is a process created by FDA to ensure that the voices, experiences, and priorities of patients and caregivers are meaningfully incorporated into drug development and regulatory decision-making. An EL-PFDD meeting is organized by the patient community—in this case, by Lipodystrophy United—with FDA staff attending in a listening capacity.
At this meeting, patients and caregivers will have the chance to speak directly about the daily impact of lipodystrophy, the symptoms that matter most, and what an ideal treatment would look like. The majority of the meeting will follow a town-hall style discussion led by patients, so that the broadest range of lived experiences are captured.
Why is this so important?
- It elevates your voices directly to regulators, researchers, and drug developers.
- It ensures the realities of living with lipodystrophy are central in drug development and evaluation.
- It creates a historic opportunity for our community to influence research priorities, future clinical trials, and treatment options.
What comes next?
- We will begin planning this meeting in collaboration with the FDA and our community partners.
- There will be many opportunities for patients, caregivers, and families to share their perspectives—through panels, open discussion, and written comments.
- A Voice of the Patient report will be developed from the meeting, which becomes part of the FDA’s public record and will inform benefit-risk assessments for therapies in development.
We will share more details—including dates, participation opportunities, and how you can get involved—in the coming months.
This is a tremendous step forward for the lipodystrophy community, and it is only possible because of the dedication, openness, and advocacy of each of you.