Compliance
Article | August 11, 2026
OIG Reaffirms: Fair Market Value Alone Does Not Eliminate Anti-Kickback Statute Risk
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Article | July 28, 2026
OIG Advisory Opinion 26‑11 Offers Guardrails for Free Diagnostic Reports
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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 05, 2026
Last Call: CMS Comments Due June 9 on Proposed Breakthrough Device NTAP Changes
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Article | May 12, 2026
Gardner Expands Compliance and Litigation Capabilities with Addition of Vivian Egbu
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Article | May 05, 2026
CMS Proposes Ending “Fast-Track” NTAP Pathways for Breakthrough Devices
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Article | April 09, 2026
FTC Turns Up the Heat on Healthcare: Key Implications for Medtech, Pharma, & Biotech Companies
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Article | April 07, 2026
OIG Advisory Opinion 25-11: Key Compliance Insights for Manufacturers
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Article | August 07, 2023
FDA Regulatory, Compliance, and Privacy Due Diligence — Finding Your Goldilocks Zone
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Article | July 17, 2023
FDA Publishes First Draft Guidance for Clinical Trials with Psychedelic Drugs
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Article | June 21, 2023
Beyond Paperwork: Assessing the Effectiveness of a Compliance Program
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Article | June 14, 2023
New WA Privacy Law ‘Turns The Beat Around’ on Drug and Device Makers
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