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Initiatives for Patients to Engage With FDA

Initiatives for Patients to Engage With FDA

 Initiative *FDA-led Patient-Focused Drug Development (PFDD) MeetingsExternally-led PFDD MeetingsNORD MOU Pilot Listening SessionsPatient Engagement Collaborative (PEC)Patient Engagement Advisory Committee (PEAC)Patient Representative Program (PRP)
PurposePublic meetings that systematically obtain the patient perspective on specific diseases and their treatmentsTo allow patient organizations to identify and organize patient-focused collaborations to generate public input on other disease areas, using the process established through FDA-led PFDD meetings as a modelPilot listening sessions in rare diseases to inform FDA staff of disease and treatment burden in rare diseases  A forum to discuss and share experiences on patient engagement in medical product development and regulatory discussionsProvides advice to the Commissioner or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients in a public advisory committee meetingFDA Patient Representative ℠ consultants provide direct input to inform the Agency's decision-making associated with medical products for drugs, biologics, and medical devices in a public advisory committee meeting or as part of agency-directed assignments
Medical Product Type CoveredBiologics, DrugsBiologics, DrugsBiologics, Devices, DrugsBiologics, Devices, DrugsDevicesBiologics, Devices, Drugs
Meeting FrequencyVariesVariesVariesQuarterlyAnnuallyOngoing
Participant statusPatients, Caregivers, and Patient AdvocatesPatients, Caregivers, and Patient AdvocatesPatients, Caregivers, and AdvocatesPatients, Caregivers and AdvocatesPatients, Caregivers and Advocates that serve as Special Government Employees**Patients, Caregivers and Advocates that serve as Special Government Employees**
Topics CoveredSymptoms and daily impacts that matter most to patients, patient perspectives on current treatment approaches, and topics such as clinical trial considerations and meaningful benefit may also be exploredFDA welcomes host organizations to have public meetings to discuss symptoms and daily impacts that matter most to patients, patient perspectives on current treatment approaches, and topics such as clinical trial considerations and meaningful benefit may also be explored.Treatment, disease burden, quality of life, division-specific questionsPatient engagement operationsRegulatory process and medical product reviewRegulatory medical product review
More InformationPFDD Externally-led PFDDNORD MOU PEC PEAC PRP

 * This list is not inclusive of all FDA Patient Engagement Initiatives.

** Special Government Employees are appointed when conflict of interest restrictions need to be applied to participants for topics that cover specific products or regulatory issues.