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Enforcement Compliance Federal Food Drug and Cosmetic Act (FFDCA)

King & Spalding

LDT Final Rule: Shifting the LDT Battlefield

King & Spalding on

On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more

King & Spalding

OIG Increases Expectations for Compliance Officers in Its New Compliance Program Guidance – What Compliance Officers at...

King & Spalding on

On November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its anticipated General Compliance Program Guidance (“GCPG”) for the health care industry. The GCPG serves as a...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Regulation and Enforcement Updates

We are pleased to present the first issue of our newsletter analyzing recent trends and developments impacting the life sciences industry, including DOJ policy updates and key provisions of the Food and Drug Omnibus Reform...more

Cozen O'Connor

Lanham Act Claims Are Not Precluded by Compliance with the FDCA

Cozen O'Connor on

POM Wonderful LLC (“POM”) produces and sells a pomegranate-blueberry juice blend. POM brought a Lanham Act suit against Coca-Cola for allegedly marketing one of its juices in such a way that it misled consumers into thinking...more

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