The pharmaceutical industry and patient advocacy groups have been avidly following the progress of the US Food and Drug Administration’s patient-focused drug development program since its launch 10 years ago. The goal of PFDD is to help ensure that patients’ experiences, perspectives, needs and priorities are incorporated throughout the drug development process and regulatory evaluation.
Under a commitment made in the 2012 reauthorization of the Prescription Drug User Fee Act (PDUFA V), the agency began holding a series of meetings with patients and stakeholders that focused on specific diseases. Patients discussed the symptoms that have the most significant impact on their daily lives, their current treatment regimens, and what factors they consider when making decisions about treatments
