Rachel Park

Rachel Park

Morrison & Foerster LLP

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FDORA Passage Brings Significant Changes To FDA’S Drug, Device, And Cosmetic Authorities

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,...more

2/8/2023  /  Center for Drug Evaluation and Research (CDER) , Clinical Trials , Consolidated Appropriations Act (CAA) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Real World Evidence

Key Takeaways From FDLI's Enforcement, Litigation, And Compliance Conference Keynote Address

FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the...more

12/22/2021  /  Clinical Trials , Consumer Protection Laws , Coronavirus/COVID-19 , Department of Justice (DOJ) , Enforcement Actions , False Statements , Food and Drug Administration (FDA) , Fraud , Opioid , Pharmaceutical Industry
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