FDORA Enacted; HP&M Issues Detailed Summary and Analysis

On December 29, 2022, the President signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023, Pub. L. No. 117-328 (2022).  FDORA primarily amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.  The law enacts significant changes that will have considerable short- and long- term effects on the regulated industry and the FDA.

FDORA includes six subtitles, Subtitle A- Reauthorizations, Subtitle B- Drugs and Biologics, Subtitle C- Medical Devices, Subtitle D- Infant Formula, Subtitle E- Cosmetics and Subtitle F- Cross-Cutting Provisions.

As we have done in the past for significant laws amending the operative food and drug statutes, Hyman, Phelps & McNamara, P.C. has prepared a detailed Summary and Analysis of FDORA.  The memorandum summarizes each section of FDORA and analyzes the new law’s potential effects on the FDA-regulated industry.