FDA to host listening session for AdComm improvements

May 1, 2024

Earlier this week, the FDA announced a public listening session scheduled for June 13, 2024, aimed at enhancing the functionality and processes of its advisory committees.

The session is part of a broader initiative to improve how these committees contribute to the FDA's regulatory decisions. Advisory committees are crucial to the FDA’s process, offering expert advice from various fields. The panels include representatives from industry, consumer groups and patient advocacy organizations, providing diverse perspectives on a range of issues from drug approvals to medical devices. Although their recommendations are non-binding, they are considered alongside other factors in the FDA’s final decision-making process.

During the upcoming virtual session, the FDA seeks public input on several key aspects: improving the representation of diverse perspectives in committee discussions, reducing administrative hurdles that may deter expert participation and enhancing public understanding of the committees' roles and contributions.

The listening session will also explore ways to modernize and streamline existing processes to make participation less burdensome and more appealing to potential committee members. This includes potential updates to the way committee discussions and votes are conducted to clarify their advisory role.

To participate in the listening session, interested parties must register by May 13, with priority given to early registrants. Comments and feedback can also be submitted in writing via the FDA’s official website until August 13, 2024.