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Enforcement Compliance Food and Drug Administration (FDA)

Fenwick & West LLP

Disclosure Trend: Risk Factors Post-Chevron

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Life sciences companies are adding risk factor language in response to the U.S. Supreme Court overturning the Chevron Doctrine. As you may recall, the U.S. Supreme Court recently overturned the Chevron Doctrine....more

Arnall Golden Gregory LLP

The Boys Are Back in Town: FDA’s Draft Guidance for Compliance With the Phase-Out of LDT Enforcement Discretion

Thin Lizzy famously declared in their 1976 hit, “The Boys are Back in Town.” The same is true almost 50 years later, as the U.S. Food and Drug Administration has announced its plan to phase out its general enforcement...more

King & Spalding

LDT Final Rule: Shifting the LDT Battlefield

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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

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

King & Spalding

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

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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

Mintz - Health Care Viewpoints

FDA Delays Enforcement of MoCRA Facility Registration and Cosmetic Product Listing Requirements

Since the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law (see our previous blog post detailing the law here), cosmetics companies have spent the past year preparing to comply with its...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

McDermott Will & Emery

[Event] Life Sciences Boot Camp For In-House Counsel 2023 - April 4th, South San Francisco, CA

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McDermott is pleased to bring our Life Sciences Boot Camp for In-House Counsel back to the Bay Area! Amid turbulent economic forces, life sciences companies continue to grapple with increasingly complex legal and business...more

Hinch Newman LLP

Advertising Law Alert: FTC Announces New Health Products Compliance Guidance

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In December 2022, the the Federal Trade Commission published new guidance regarding representations about the benefits and safety of health-related products: Health Products Compliance Guidance. Federal Trade Commission...more

Gardner Law

Anti-Fraud & Sunshine Update

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Staying up-to-date with fraud enforcement trends and recent cases and settlements can sometimes be viewed as a “Glass Half Empty” perspective, focusing on negative aspects of the industry and the perceived threat of...more

Arnall Golden Gregory LLP

Quality Agreements: An AGG Podcast Recap

A few weeks ago, AGG’s Food and Drug Practice Team launched its podcast series to discuss topics affecting the FDA-regulated industry. The series, called “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues,”...more

Arnall Golden Gregory LLP

I Can’t Drive 55: The Law is the Law and FDA is the Enforcer

The Red Rocker, Sammy Hagar, sang in 1984, “I Can’t Drive 55.”  When counseling clients at our Firm about the potential of enforcement risk by the Food and Drug Administration (or any other regulatory authority for that...more

Hogan Lovells

Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership

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Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more

Cozen O'Connor

Lanham Act Claims Are Not Precluded by Compliance with the FDCA

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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

The Volkov Law Group

Congressional Investigations: Unique And Significant Risks

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We have all watched the familiar scene on Capitol Hill – the latest public scandal like officials from the Internal Revenue Service are dragged up to Capitol Hill to appear before a Committee, raise their right hands, take...more

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