The Consolidated Appropriations Act for 2023 was signed into law on December 29, 2022 and includes the Food and Drug Omnibus Reform Act (FDORA). FDORA authorizes a variety of new and important amendments to the Food, Drug, and Cosmetic Act (FDCA) governing drugs, medical devices, and clinical trials, as well as cosmetics and other personal care products. FDORA enacts many of the amendments to the FDCA that were previously drafted and negotiated as part of Congress’s reauthorization of the U.S. Food and Drug Administration’s (FDA) user fee programs.
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