Caroline Kessler

Akin Gump Strauss Hauer & Feld LLP

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Latest Posts › Regulatory Oversight

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Five FDA Takeaways from the FY26 Budget

On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...more

6/3/2025 / Department of Health and Human Services (HHS) , Drug Pricing , Federal Budget , Food and Drug Administration (FDA) , Government Agencies , Healthcare , Medical Devices , Regulatory Oversight , Regulatory Reform , Trump Administration

District Court Vacates FDA LDT Rule; What’s Next for Regulation of Lab Testing?

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more

4/4/2025 / Appeals , Clinical Laboratories , Final Rules , Food and Drug Administration (FDA) , Healthcare , Judicial Authority , Laboratory Developed Tests , Medical Devices , Regulatory Oversight , Regulatory Requirements

FDA Finalizes LDT Regulation, with Significant Exceptions: Enforcement of Requirements Will Phase In over Four Years

On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set to be officially published on May 6, this...more

5/2/2024 / CLIA , Enforcement , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Regulatory Oversight

Food for Thought: FDA Proposes New Vision for the Human Foods Program

On January 31, 2023, the U.S. Food and Drug Administration (FDA) announced a proposal to restructure the agency’s human foods program. FDA regulates almost 80 percent of the nation’s food supply and this work is a cornerstone...more

2/2/2023 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Public Health , Regulatory Oversight

FDA Harshes the CBD Buzz; is it High Time for Congress to Step In?

The U.S. Food and Drug Administration (FDA) announced the conclusion of an internal working group that cannabidiol (CBD) will require a new regulatory pathway. The FDA explicitly denied three citizen petitions urging the...more

1/30/2023 / Cannabidiol (CBD) oil , Decriminalization of Marijuana , Dietary Supplements , Food and Drug Administration (FDA) , Marijuana , Regulatory Agenda , Regulatory Oversight , Working Groups

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