Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

Animal testing no longer required for all new drugs approved by FDA

The bill was first introduced by Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) in the Senate, and it was approved unanimously.

COVID-19 PHE extended to mid-April

The renewal comes as the country is facing another wave of COVID-19 infections, this time from a new variant identified as XBB.1.5.

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Cardiologists push for a more diverse, inclusive healthcare workforce

A recent roundtable discussion focused on how today's healthcare leaders can "begin to dismantle the systems that perpetuate inequities in medicine and build new systems that promote diversity, equity and inclusive excellence."

FDA announces recall of adrenaline lots

Spectrum Laboratory Products is voluntarily recalling the lots after customer complaints found the adrenaline to be discolored.

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HHS to release first wave of drugs up for price negotiations Sept. 1

HHS is moving forward with drug price negotiations afforded to CMS under the Inflation Reduction Act.

FDA approves new Alzheimer’s disease drug

The U.S. Food and Drug Administration (FDA) approved a new drug treatment for Alzheimer’s disease, Leqembi (lecanemab).

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Amazon’s $4B acquisition of Medical One clears regulators in Oregon

Amazon has overcome another step toward acquiring primary care group One Medical for $3.9 billion after the Oregon Housing Authority cleared the deal.

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GE HealthCare stands on its own

GE has completed the spinoff of its healthcare business, and GE HealthCare began trading as its own entity on the Nasdaq Jan. 4.

Around the web

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

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