Regulatory & Compliance

FDA Device Approvals Rise Despite Staffing Cuts
Regulatory & Compliance FDA Device Approvals Rise Despite Staffing Cuts

In a surprising display of resilience, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) not only maintained its operational tempo but also increased its authorization of novel medical devices in 2025, a period marked by significant staff reductions under the

Is PBM Transparency the Key to Cheaper Drugs?
Regulatory & Compliance Is PBM Transparency the Key to Cheaper Drugs?

A Federal Reckoning: Targeting the Middlemen of Medicine The persistent and escalating cost of prescription drugs in the United States has ignited widespread public frustration and become a recurring battleground in political debate. A proposed rule from the Department of Labor (DOL) is now taking

Trend Analysis: Medicaid Provider Taxes
Regulatory & Compliance Trend Analysis: Medicaid Provider Taxes

A decades-old financial partnership between states and healthcare providers is now facing an unprecedented federal challenge, threatening to reshape the funding landscape of the nation's largest health insurance program. The Centers for Medicare & Medicaid Services (CMS) has finalized a rule that

Will a New Rule Cut Medicare Advantage Benefits?
Regulatory & Compliance Will a New Rule Cut Medicare Advantage Benefits?

A Looming Showdown: The Battle Over Medicare Advantage Payments For the more than 35 million American seniors enrolled in Medicare Advantage (MA) plans, the promise of comprehensive coverage and extra benefits is a cornerstone of their healthcare. However, a seismic shift may be on the horizon. The

Why Did Integra Recall Wound Devices Linked to 14 Injuries?
Regulatory & Compliance Why Did Integra Recall Wound Devices Linked to 14 Injuries?

Patient Safety in Question Unpacking the Integra Wound Care Recall When a medical device intended to heal instead causes harm, it strikes at the core of patient trust, demanding an immediate and thorough investigation into what went wrong. Medical device company Integra LifeSciences has initiated a

Will a Cigna Settlement Lower Insulin Costs?
Regulatory & Compliance Will a Cigna Settlement Lower Insulin Costs?

The intricate web connecting pharmaceutical manufacturers to patient medicine cabinets is quietly being rewoven as a landmark settlement threatens to expose the secretive financial mechanics driving America's insulin crisis. For years, the rising cost of this life-saving medication has been a

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