What Are Externally-Led Patient-Focused Drug Development (EL-PFDD) Meetings?
Externally-Led Patient-Focused Drug Development (EL-PFDD) meetings are special gatherings created to bring the real-world experiences and voices of patients and caregivers directly to the center of decision-making about new treatments and research.
Established by the U.S. Food and Drug Administration (FDA), the Patient-Focused Drug Development (PFDD) initiative aims to ensure the concerns, needs, and priorities of people living with serious medical conditions—like Diabetic Retinal Disease (DRD)—are understood by FDA, product developers, clinicians, and academic researchers and used to guide the development and evaluation of new therapies.
Externally-led simply means that a patient advocacy group (like The Mary Tyler Moore Vision Initiative), rather than the FDA itself, hosts the meeting. These meetings typically follow a format designed by the FDA and present an opportunity for the patient community to share:
- Experiences living with or caring for someone with the disease.
- Symptoms and daily impacts that matter the most.
- Services, treatments, or other approaches that have helped—or not.
- Hopes and priorities for future research and better treatments.
After each EL-PFDD meeting, these insights are gathered into a “Voice of the Patient” report that is shared with the FDA, product developers, clinicians, and academic researchers. The goal is to make sure the people whose lives are affected by a disease have a clear and lasting impact on how new therapies are developed and evaluated.
These meetings empower patients, their caregivers, and families, and help the whole community—including clinicians, industry, and policy makers—better understand what truly matters to those living with the condition.
