Larry J Bauer, Senior Regulatory Drug Expert from Hyman, Phelps, & McNamara PC, a dedicated food and drug law firm, discusses the history and purposes of patient-focused drug development (PFDD) meetings.
As Mr. Bauer explains, PFDD meetings are designed to engage patients and learn their perspectives on the most significant symptoms of their condition and the impact of the condition on daily life, as well as their current approaches to treatment.
In 2012, the U.S. Food and Drug Administration (FDA) initiated PFDD meetings to more systematically obtain patient perspectives on diseases, both rare and non-rare, as well as their currently available treatments. Furthermore, PFDD meetings provide the FDA and other key stakeholders an opportunity to hear from patients, their families, caregivers, and patient advocates directly about the symptoms that matter most to them, the impact of disease on daily life, and patients’ experiences with currently available treatments. This input may inform FDA’s decisions and oversight during drug development as well as during the review of marketing applications.
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