This is the first FDA committee that is only comprised of patients, patient advocates and caregivers. The committee will discuss and make recommendations at each stage of product development — including design, clinical trials and ultimately product approval.
While the FDA has objective and consistent criteria for approval, involving the end user to identify health priorities and outcomes will provide the FDA with “rigorous, systematically gathered patient preference information as part of the totality of evidence from clinical and nonclinical testing,” wrote FDA Commissioner Scott Gottlieb, MD.
“Patients are increasingly collecting much of this real world data. Patients are spearheading the creation of novel registry platforms that collect health data to track their progress, and facilitate medical product evaluations. We’re fostering interactions with these patient-led registries to help them become vehicles for regulatory change,” Dr. Gottlieb added.
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