FDA-led Patient-Focused Drug Development (PFDD)
	Initiative	FDA-led Patient-Focused Drug Development
	Purpose	Public meetings that systematically obtain the patient perspective on specific diseases and their treatments
	Medical Product Type Covered	Biologics, Drugs
	Meeting Frequency	Varies
	Participant Status	Patients, Caregivers and Advocates that serve as Special Government Employees
	Topics Covered	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 PFDD

Externally-led PFDD Meetings
	Initiative	Externally-led PFDD Meetings
	Purpose	To 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 Covered	Biologics, Drugs
	Meeting Frequency	Varies
	Participant Status	Patients, Caregivers and Advocates
	Topics Covered	FDA 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
	Initiative	NORD MOU Pilot Listening Sessions
	Purpose	Pilot listening sessions in rare diseases to inform FDA staff of disease and treatment burden in rare diseases
	Medical Product Type Covered	Biologics, Devices, Drugs
	Meeting Frequency	Varies
	Participant Status	Patients, Caregivers and Advocates
	Topics Covered	Treatment, disease burden, quality of life, division-specific questions.
More Information	Learn more about Listening Sessions

Patient Engagement Collaborative (PEC)
	Initiative	Patient Engagement Collaborative (PEC)
	Purpose	A forum to discuss and share experiences on patient engagement in medical product development and regulatory discussions
	Medical Product Type Covered	Biologics, Devices, Drugs
	Meeting Frequency	Quarterly
	Participant Status	Patients, Caregivers and Advocates
	Topics Covered	Patient engagement operations
More Information	Learn more about PEC

Patient Engagement Advisory Committee (PEAC)
	Initiative	Patient Engagement Advisory Committee (PEAC)
	Purpose	Provides 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 Covered	Devices
	Meeting Frequency	Annually
	Participant Status	Patients, Caregivers and Advocates that serve as Special Government Employees**
	Topics Covered	Regulatory process and medical product review
More Information	Learn more about PEAC

Patient Representative Program (PRP)
	Initiative	Patient Representative Program (PRP)
	Purpose	Provides 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 Covered	Biologics, Devices, Drugs
	Meeting Frequency	Annually
	Participant Status	Patients, Caregivers and Advocates that serve as Special Government Employees**
	Topics Covered	Regulatory 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.