News & Analysis as of

Enforcement Actions Marketing Medical Devices

Morgan Lewis

Seventh Circuit Overturns AKS Conviction in DME Marketing Case

Morgan Lewis on

The US Court of Appeals for the Seventh Circuit recently issued a decision that has important implications for stakeholders in the durable medical equipment (DME), medical device, and telehealth space as well as future civil...more

Epstein Becker & Green

New Seventh Circuit Decision Signals Greater Flexibility for Healthcare Marketing Services

Epstein Becker & Green on

On April 14, 2025, the United States Court of Appeals for the Seventh Circuit issued a decision in a case involving the federal Anti-Kickback Statute (“AKS”) and marketing services that the court framed as an appeal...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

Ropes & Gray LLP

FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis

Ropes & Gray LLP on

On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - March 2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Akin Gump Strauss Hauer & Feld LLP

Checking In On FDA’s Enforcement Discretion Policy for Laboratory Developed Tests

• In a recent warning letter, the Food and Drug Administration (FDA) advised a laboratory to seek marketing authorization for its genetic tests that qualified as laboratory developed tests (LDTs)—which have largely benefited...more

Hogan Lovells

New York Regulators Lead the Charge to Fill Health Data Protection Gaps Left by Federal Law

Hogan Lovells on

New York AG Settles Data Protection Enforcement Against Mobile Health Apps - After a year-long investigation into mobile health apps claiming to be able to measure vital signs or health indicators through smartphone...more

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