FDA Launches New System for Requesting Non-Industry Stakeholder Meetings
Patient groups and other non-industry stakeholders can now request meetings with staff from the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) through a new online system.
FDA says the new external stakeholder meeting request (ESMR) system will help non-industry groups, such as patient advocacy groups and healthcare professionals, meet with CDER staff to discuss drug development and safety issues more easily.
"Meetings with patient advocacy groups, health care professionals, and other non-industry stakeholders are invaluable to our work. They provide a mechanism for communicating and sharing ideas with one another to improve efficiency and advance medical product development," FDA writes.
To request a meeting, stakeholders must complete an online form on FDA's website and provide their name, the name of their organization, as well as the topic and goal of the meeting being sought.
Stakeholders are also asked to provide their affiliation and the affiliation of any other potential attendees, as well as an agenda and questions for the agency.
Meeting requests will be reviewed by FDA's professional affairs and stakeholder engagement staff, though stakeholders interested in meeting with FDA on issues other than drug development or drug safety are encouraged to contact FDA's Office of Health and Constituent Affairs.