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  1. Learn About FDA Patient Engagement

FDA Patient Engagement Overview*

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 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 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.

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