FDA Mulls Establishing Patient Affairs Office to Support Drug Development

The FDA is considering establishing a new office for patient affairs to support the agency’s efforts to engage patients in the drug development process.

The agency is inviting comments for 90 days on the proposal, which responds to calls from stakeholders for more centralized patient engagement.

The office is intended to improve patient engagement in the development process across product centers — such as CDER and CBER — with improved transparency and accessibility. It would focus on developing a better understanding of patient experiences with diseases, and on familiarizing patients and advocates with the FDA’s regulatory processes.