FDA has opened a public docket in the Federal Register for input on a new Office of Patient Affairs and other initiatives, both ongoing and potential, to provide a more transparent, accessible, and robust experience for patients. This effort builds on feedback received by FDA to a previous public docket regarding that agency’s stakeholder responsibilities as outlined in the Food and Drug Administration Safety and Innovation Act (FDASIA).

The objectives for the current public docket include soliciting ideas on:

• Developing an enhanced understanding of the patient experience of disease
• Improving support for patients and their advocates in understanding regulatory processes and navigating the FDA
• Exploring the idea of an Office of Patient Affairs, which would “offer a single point of entry to the Agency for the patient community”
• Hosting and maintaining robust data management systems that would incorporate and formalize knowledge shared with FDA by patient stakeholders and communities
• Developing a scalable and forward-looking platform for communicating with patient stakeholders, particularly via online channels

The public docket, FDA-2017-N-0455, is available here. Comments will be accepted until June 12.