FDA Patient Engagement Opportunities

 

Patient Listening Sessions

The FDA hosts a series of Patient Listening Session meetings 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 (NORD) and the Reagan-Udall Foundation for FDA (RUF).

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® 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 (and sometimes Regular 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 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 (PCC)

The Patient and Caregiver Connection (PCC) is a program with FDA’s Center for Devices and Radiological Health (CDRH). PCC partners with patient organizations to provide a means for FDA staff to formally engage with patients and care-partners. This helps FDA to understand experiences of living with their specific disease or condition and using medical devices in the diagnosis, treatment or management of their disease, as well current issues or trends related to medical devices. Engaging with patients and caregivers through the Patient and Caregiver Connection enhances CDRH's ability to hear, understand, and integrate their perspectives in the course of its work.