The Act introduces key reforms to the FDA regulatory framework relating to drugs, biological products, and cosmetics, among others.

On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (the Act),1 which passed in the House of Representatives by a vote of 225-201 and in the Senate by a vote of 68- 29.2 While central provisions of the Act concern federal appropriations, including appropriations to the Food and Drug Administration (FDA), the Act also contains the Food and Drug Omnibus Reform Act of 2022 (FDORA), which contains material amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) and Public Health Service Act (PHSA). FDORA thus reforms the FDA regulatory framework relating to drugs, biological products, medical devices, and cosmetics, among others.