Food and Drug Omnibus Reform Act: A Critical Course Correction

On December 29, 2022, the Consolidated Appropriations Act, 2023 (Public Law No. 117-328) was signed into law, containing the Food and Drug Omnibus Reform Act of 2022 (FDORA), which introduces significant reforms to the US Food and Drug Administration (FDA).1 This paper highlights select provisions of FDORA that, in our view, have broad implications for the clinical and pharmaceutical sectors, such as promoting clinical trial diversity, revising the accelerated approval process, modernizing clinical trial operations, updating marketing exclusivities, expanding cosmetics regulation, and fortifying infant formula oversight.
Source: Mayo Clinic Proceedings - Category: Internal Medicine Authors: Tags: Perspectives and controversies Source Type: research