In December 2016, the bipartisan 21st Century Cures Act (P.L. 114-255) was enacted, marking a pivotal milestone in advancing a patient-focused drug development (PFDD) paradigm. This law directed the Food and Drug Administration (FDA) to develop and implement strategies to solicit view of patients during the medical product development process and consider the perspectives of patients during regulatory discussions. Over the past decade, FDA has steadily taken steps to implement the 21st Century Cures Act patient-focused drug development provisions, including through meetings by which patients, caregivers, family members and patient advocates, among others, have been able to provide information about patients’ experiences with a disease or condition. The opportunity to provide such feedback through these patient-focused meetings is a key pillar of the agency’s patient-focused drug development engagement.