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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Article | August 06, 2026

AI Clinical Decision Support Software: The New Regulatory Reality for Digital Health and Life Sciences, Pt 2

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Article | August 04, 2026

AI Clinical Decision Support Software: The New Regulatory Reality for Digital Health and Life Sciences, Pt 1

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Article | August 03, 2026

CMS Grandfathers Certain Breakthrough Devices for NTAP and TPT

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Article | July 30, 2026

FDA Finalizes Risk-Based Framework for Human Factors Information in Medical Device Submissions

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Article | July 28, 2026

OIG Advisory Opinion 26‑11 Offers Guardrails for Free Diagnostic Reports

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Article | July 23, 2026

Introducing: The Comment Period

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Article | July 22, 2026

FDA's Anticipated Proposed Rulemaking for Direct-to-Consumer Advertising

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Article | July 21, 2026

Rebecca Zadaka and Paul Rothermel Named 2026 Super Lawyers Rising Stars

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Article | July 16, 2026

Is Your Company’s AI Use A Cybersecurity Gap?

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Article | July 09, 2026

MDUFA VI Is Taking Shape: What Device Companies Should Do Now

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Article | July 07, 2026

CMS Launches New Office Focused on AI, Interoperability & Digital Health

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Article | July 02, 2026

FDA's Expanded Decision Tree: What Food Manufacturers Should Know About FDA's New Toxicity Screening Tool

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Article | June 30, 2026

Vermont’s New Privacy Law Comes with Broad Consumer Health Data Requirements

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Article | June 25, 2026

CMS Proposes Stronger Enforcement Tools for Open Payments Audits

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Article | June 23, 2026

OIG Advisory Opinion 26‑10 Signals Scrutiny of Royalty‑Based HCP Consulting Arrangements

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Article | June 18, 2026

FDA's New One-Day Inspection Pilot: More Efficient Oversight or More Questions Than Answers?

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Article | June 16, 2026

FDA’s Drug Repurposing Initiative Signals a Shift in Regulatory Strategy

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Article | June 12, 2026

Join Us in Welcoming Summer Associates Hannah Brekke and Patricia Leftwich

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