Join us for a meaningful conversation with panelists and audience members to discuss what matters most to GBS, MMN, ant Anti-Mag patients in drug development. This will be an Externally-Led Patient Focused Drug Development meeting.
Patient-Focused Drug Development (PFDD) is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation. The PFDD initiative started in 2012 as part of FDA’s commitments under the Prescription Drug User Fee Act (PDUFA) V. After conducting FDA-led PFDD meetings, FDA recognized there are many more diseases/conditions that can be addressed beyond those that were planned and conducted by FDA. To help expand the benefits of FDA’s PFDD initiative, in 2015, FDA announced the opportunity for externally-led (EL-PFDD) meetings. EL-PFDD meetings are planned and hosted by patient organizations, with the input of FDA staff, and use the process established by FDA-led PFDD meetings as a model.
Audience members who are patients or care partners of patients living with GBS, MMN, or Anti-Mag will be encouraged to add their voice to the discussion being led by a group of patient panelists and expert moderators. Join us for all of the meeting or a portion of it.
Agenda:
https://www.gbs-cidp.org/2024elpfdd/