FDA’s Robyn Bent On The Evolution of Patient-Focused Drug Development

The director of the agency’s patient-focused drug development program talks about how the program has improved the development and evaluation of new drugs, initiatives underway, and plans to standardize and harmonize the process.

PFDD decade — Director of US FDA's patient-focused drug development program talks about its accomplishments and future initiatives • Source: Shutterstock

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...