Laws & Regulations

J&J Heart Pump Flaw Linked to 22 Serious Injuries
Regulatory & Compliance J&J Heart Pump Flaw Linked to 22 Serious Injuries

In the high-stakes environment of cardiac care, where precision instruments can mean the difference between life and death, the reliability of medical technology is paramount. A significant safety concern has now emerged surrounding a critical device, as Johnson & Johnson's subsidiary, Abiomed,

FDA Refuses to Review Moderna's mRNA Flu Vaccine
Regulatory & Compliance FDA Refuses to Review Moderna's mRNA Flu Vaccine

A Regulatory Standoff with High Stakes In a move that sent shockwaves through the biotechnology sector, the U.S. Food and Drug Administration (FDA) has taken the extraordinary step of refusing to conduct a formal review of Moderna's biologics license application for its mRNA-based influenza

CMS Proposes Major Overhaul of ACA Insurance Marketplace
Regulatory & Compliance CMS Proposes Major Overhaul of ACA Insurance Marketplace

With the healthcare landscape in constant flux, the latest proposal from the Centers for Medicare & Medicaid Services aims to reshape the Affordable Care Act marketplaces. To help us understand these sweeping changes, we're speaking with James Maitland, a leading expert on U.S. health insurance

Why Did a Lawsuit Kill the 340B Drug Rebate Pilot?
Regulatory & Compliance Why Did a Lawsuit Kill the 340B Drug Rebate Pilot?

A federal policy designed to overhaul a critical drug pricing program for the nation's most vulnerable hospitals was dismantled not by political debate or public outcry, but by a precise legal maneuver that halted its implementation just days before it was set to begin. The swift and total collapse

Will TrumpRx Actually Lower Your Drug Costs?
Regulatory & Compliance Will TrumpRx Actually Lower Your Drug Costs?

With the recent launch of the TrumpRx portal, the White House has waded directly into the complex world of pharmaceutical sales, promising lower prices for Americans. To unpack the real-world implications of this move, we're speaking with James Maitland, a leading analyst whose work has

Will This FTC Deal Finally Lower Drug Costs?
Regulatory & Compliance Will This FTC Deal Finally Lower Drug Costs?

In a significant challenge to the long-criticized practices that drive up prescription drug costs in the United States, the Federal Trade Commission (FTC) has finalized a landmark settlement with Express Scripts, one of the nation’s most powerful pharmacy benefit managers (PBMs). This agreement

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