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.
FDA recognizes that there are many more disease areas that can be addressed beyond the PFDD meetings planned and conducted by the FDA. To help expand the benefits of FDA’s PFDD program FDA welcomes patient organizations to identify and organize patient-focused collaborations to generate public input on other disease areas, using the process established by FDA-led PFDD meetings as a model.
Overview of the EL-PFDD Program (PDF - 159KB)
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