The Patient-Focused Drug Development (PFDD) program aims to more systematically obtain the patient perspective on specific diseases and their treatments. The patient perspective is critical in helping FDA understand the context in which regulatory decisions are made for new drugs. PFDD meetings give FDA and other key stakeholders, including medical product developers, health care providers, federal partners, an important opportunity to hear directly from patients, their families, caregivers, and patient advocates about the symptoms that matter most to them, the impact the disease has on patients’ daily lives, and patients’ experiences with currently available treatments. This input can inform FDA’s decisions and oversight both during drug development and during our review of a marketing application.
There is opportunity to participate in person and virtually at this meeting. The meeting will be live streamed on Tuesday March 5th, 2024. We will also have a comment form open on our website before and after the meeting, those comments will be included in the Voice of the Patient Report published after the meeting.