Health Affairs July 1, 2024
The Food and Drug Administration (FDA) advisory committees play a critical role in providing outside expertise to agency officials on key decisions such as medical product approvals or safety actions, and by informing scientific debate on questions that shape FDA regulatory policy. In recent years, several senior FDA officials have publicly hinted at possible advisory committee reforms, following increased attention to advisory committee meetings during the COVID-19 pandemic and controversial agency approvals that deviated from committee recommendations.
On June 13, 2024, the FDA hosted a public listening session on “Optimizing FDA’s Use and Processes for Advisory Committees” and outlined three areas of discussion signaling where reforms are being considered: composition of advisory committees, service on advisory committees as special government...
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