Article | October 27, 2026

Credit Where It’s Earned: How Regulators Are Weighing Compliance Programs When Setting Penalties

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Article | October 20, 2026

OIG Protects Device Affiliate’s Hearing Referral Fees

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Article | October 13, 2026

DOJ Fraud Division Prioritizes Health Care

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Article | October 08, 2026

MAHA Goes to the States: The Emerging Patchwork of Food Regulation

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Article | October 06, 2026

Audits Are More Than a Check-the-Box Exercise

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Article | October 02, 2026

The Comment Period, Ep. 5: How I Met Your Regulator

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Article | October 01, 2026

You Don’t Know What You’ve Got ’til It’s Gone: Regulatory Strategy for a Strained FDA

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Article | September 28, 2026

Could New Anti-Kickback Protections Support Clinical Trial Participation?

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Article | September 24, 2026

Hannah Brekke Joins Gardner Law as Law Clerk

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Article | September 22, 2026

Gardner Law Expands Privacy and AI Practice with Addition of Mercy Ulo

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Article | September 21, 2026

The Comment Period, Ep. 4: Recall Me, Maybe?

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Article | September 17, 2026

FDA Seeks Input on Regulatory Framework for Generative AI-Enabled Medical Devices

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Article | September 15, 2026

Food as Medicine, Digital Health, and Medical Devices: The Next Frontier in Healthcare Compliance

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Article | September 10, 2026

Don’t Fax First and Ask Questions Later

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Article | September 08, 2026

Can You Say It in 30 Seconds? Short-Form Video and the Limits of Promotional Compliance

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Article | September 03, 2026

The Comment Period, Ep. 3: Move Fast and Get Clearance

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Article | September 03, 2026

RAPID Promises Faster Medicare Coverage, With Limits

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Article | September 02, 2026

FTC Targets Health Data Sharing and Privacy Claims

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Article | August 27, 2026

DOJ's 2026 Fraud Takedown Signals Data-Driven Enforcement

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Article | August 25, 2026

Veloxis Resolution Highlights Payment and Reporting Risks

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Article | August 20, 2026

FDA Proposes Mandatory GRAS Notification, but Stops Short of Premarket Approval

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Article | August 18, 2026

The Comment Period, Ep. 2: The Code Never Bothered Me Anyway

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Article | August 13, 2026

FDA Announces Fiscal Year 2027 Medical Device User Fees

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Article | August 11, 2026

OIG Reaffirms: Fair Market Value Alone Does Not Eliminate Anti-Kickback Statute Risk

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