FDA’s latest efforts in patient-focused drug development… now in full swing!


Patients are very much at the center of what FDA does, and the agency has long sought input from patients and caregivers regarding their treatment options and needs. For many years, FDA has included the patient perspective at advisory committee meetings and during the review of new medical products in selected meetings with FDA and product developers.

More recently, FDA has encouraged and fostered the use of patient-reported outcome measures in clinical trials, such as impact on quality of life or pain control, to support labeling claims in medical product development. We are excited about our current efforts to expand the role of the patient perspective: the agency’s Patient-Focused Drug Development initiative. Part of FDA’s commitment under thefifth authorization of the Prescription Drug User Fee Act (PDUFA V), this initiative will gather patients’ perspectives on the impact of a condition on daily life and the available therapies to treat that condition.  Read more