Initiatives for Patients to Engage With FDA
|Initiative *||FDA-led Patient-Focused Drug Development (PFDD) Meetings||Externally-led PFDD Meetings||NORD MOU Pilot Listening Sessions||Patient Engagement Collaborative (PEC)||Patient Engagement Advisory Committee (PEAC)||Patient Representative Program (PRP)|
|Purpose||Public meetings that systematically obtain the patient perspective on specific diseases and their treatments||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||Pilot 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 discussions||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||FDA 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 Covered||Biologics, Drugs||Biologics, Drugs||Biologics, Devices, Drugs||Biologics, Devices, Drugs||Devices||Biologics, Devices, Drugs|
|Participant status||Patients, Caregivers, and Patient Advocates||Patients, Caregivers, and Patient Advocates||Patients, Caregivers, and Advocates||Patients, Caregivers and Advocates||Patients, Caregivers and Advocates that serve as Special Government Employees**||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||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.||Treatment, disease burden, quality of life, division-specific questions||Patient engagement operations||Regulatory process and medical product review||Regulatory medical product review|
|More Information||PFDD||Externally-led PFDD||NORD 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.