Abstract
Abstract The dominant position of the U.S. Food and Drug Administration (FDA) as the most influential regulator in the world has been particularly salient during the COVID-19 pandemic, in the context of COVID-19 vaccines’ emergency use authorizations. In the context of adjustment toward a post-COVID-19 regulatory order of harmonization for medicines approval, this essay proposes a critical reflection about the justifications and political dynamics behind the FDA’s power and its impact in latinamerican countries’ regulatory systems, considering the already regulatory reliance on the FDA. In particular, this essay asks whether regulatory ‘agility’ and ‘coordination’ will benefit countries of the region in addressing the problems of scarcity and inequitable access to medicines that have become evident with the pandemic.
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