FDA Patient Engagement Opportunities

 

Patient Listening Sessions

The FDA hosts a series of Patient Listening Sessions that allow patients and caregivers to share their experiences living with a disease or condition and share the most urgent needs with FDA staff to help inform medical product development. This is a collaboration with the National Organization for Rare Disorders and the Reagan-Udall Foundation for the FDA.

Patient Engagement Collaborative (PEC)

The Patient Engagement Collaborative (PEC) is a patient group established by FDA and the Clinical Trials Transformation Initiative (CTTI). The PEC is composed of individuals and patient organization 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® is one of the agency’s primary mechanisms for recruiting patients and caregivers who have experience with a disease, condition or medical device. FDA patient representatives are appointed as special government employees to participate in important agency directed assignments.

Patient-Focused Drug Development Initiative (PFDD)

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

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 established the PEAC to help assure 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 (PCC)

The Patient and Caregiver Connection is a program with the FDA’s Center for Devices and Radiological Health (CDRH). The Patient and Caregiver Connection is a partnership that provides CDRH staff with broad and timely access to patient and caregiver experiences. Partner organizations will collect feedback specific issues from their members and share that feedback with CDRH. This patient feedback on the impact of the medical condition on individual patients can help provide a rich context for regulatory decision-making.