Pharmaceutical Executive September 29, 2022
Agency releases a series of new guidances to advance the reliability of patient-focused tools and methods.
Ten years ago, FDA launched an initiative to expand the role of patients in informing regulators and sponsors on most harmful effects of a disease and primary goals of treatment that can lead to desirable medical approaches. To further advance and refine the process, the agency is highlighting how the patient-focused drug development (PFDD) program has encouraged active involvement of many patient groups in bringing their perspectives into the process of developing, testing, and approving new medicines.
The primary goal of PFDD is to “better incorporate the patient’s voice in drug development and evaluation,” says Theresa Mullin, associate director for strategic initiatives in the...