FDA Patient Engagement Opportunities

 

Patient Listening Sessions

Patient Listening Sessions are done in partnership with the National Organization for Rare Disorders (NORD). Patient Listening Sessions are a resource for the FDA medical product Centers to engage with patients or their advocates. Through Patient Listening Sessions patient communities can share their experience with a disease or condition by talking directly with FDA staff. Listening Sessions can either be FDA-requested (where FDA has a specific set of questions to ask) or patient-led (when a patient community wants to share their perspectives with the FDA).

Patient Engagement Collaborative (PEC)

The Patient Engagement Collaborative (PEC) is an FDA patient group established in collaboration with the Clinical Trials Transformation Initiative (CTTI). The PEC is composed of patient organization and individual representatives who discuss topics focusing on enhancing patient engagement in medical product development and regulatory discussions at FDA.

FDA Patient Representative Program

The FDA Patient Representative Program® offers patients and caregivers the opportunity to provide critical advice to the agency as it regulates medical products—drugs, biologics, and devices. The role of the FDA Patient Representative® is unique. Patients and advocates are appointed as Special Government Employees (temporary employees) to provide direct input to agency staff as they share valuable insight on their experiences with various diseases, conditions, and devices while gaining access to confidential information.

Patient-Focused Drug Development Initiative (PFDD)

Patient-Focused Drug Development (PFDD) is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation. As experts in what it is like to live with their condition, patients are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation.

Patient Engagement Advisory Committee (PEAC)

The Patient Engagement Advisory Committee (PEAC) is composed of patients, caregivers, and representatives of patient organizations. The FDA’s Center for Devices and Radiological Health (CDRH) established the PEAC to help assure that the needs and experiences of patients are included as part of the FDA’s discussions on complex issues involving the regulation of medical devices and their use by patients.

Patient & Caregiver Connection (P&CC)

The Patient and Care-Partner Connection (P&CC) is a program with FDA’s Center for Devices and Radiological Health (CDRH). P&CC partners with patient organizations to provide a means for FDA staff to formally engage with patients and care-partners who share their individual experiences living with their disease or condition and/or their experiences with using medical devices for treatment, diagnosis, or assessment.