FDA-led Patient-Focused Drug Development (PFDD)
InitiativeFDA-led Patient-Focused Drug Development
PurposePublic meetings that systematically obtain the patient perspective on specific diseases and their treatments
Medical Product Type CoveredBiologics, Drugs
Meeting FrequencyVaries
Participant statusPatients, 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 explored
More Information Learn more about PFDD
Externally-led PFDD Meetings
InitiativeExternally-led PFDD Meetings
PurposeTo 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 model
Medical Product Type CoveredBiologics, Drugs
Meeting FrequencyVaries
Participant statusPatients, Caregivers and Advocates
Topics CoveredFDA 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.
More Information Learn more about Externally-Led-PFDD
NORD MOU Pilot Listening Sessions
InitiativeNORD MOU Pilot Listening Sessions
PurposePilot listening sessions in rare diseases to inform FDA staff of disease and treatment burden in rare diseases
Medical Product Type CoveredBiologics, Devices, Drugs
Meeting FrequencyVaries
Participant statusPatients, Caregivers and Advocates
Topics CoveredTreatment, disease burden, quality of life, division-specific questions.
More Information Learn more about Listening Sessions
Patient Engagement Collaborative (PEC)
InitiativePatient Engagement Collaborative (PEC)
PurposeA forum to discuss and share experiences on patient engagement in medical product development and regulatory discussions
Medical Product Type CoveredBiologics, Devices, Drugs
Meeting FrequencyQuarterly
Participant statusPatients, Caregivers and Advocates
Topics CoveredPatient engagement operations
More Information Learn more about PEC
Patient Engagement Advisory Committee (PEAC)
InitiativePatient Engagement Advisory Committee (PEAC)
PurposeProvides 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 meeting
Medical Product Type CoveredDevices
Meeting FrequencyAnnually
Participant statusPatients, Caregivers and Advocates that serve as Special Government Employees**
Topics CoveredRegulatory process and medical product review
More Information Learn more about PEAC
Patient Representative Program (PRP)
InitiativePatient Representative Program (PRP)
PurposeProvides 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 meeting
Medical Product Type CoveredDevices
Meeting FrequencyAnnually
Participant statusPatients, Caregivers and Advocates that serve as Special Government Employees**
Topics CoveredRegulatory process and medical product review
More Information Learn more about 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.