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Posts tagged with "FDA"

FDA Says 10 Children Killed by COVID Vaccine Spurring Review of Childhood Vaccines National News

FDA Says 10 Children Killed by COVID Vaccine Spurring Review of Childhood Vaccines

The Food and Drug Administration says that data shows that the COVID-19 vaccines caused the deaths of 10 children and the Department of Health and Human Services (HHS) is using this conclusion to justify further review of childhood vaccines. Over the weekend, FDA Commissioner Marty Makary announced that data "accumulated during the...
National News

Trump and Kennedy Announce Tylenol Causes Autism

On Monday, President Donald Trump and Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. said in a press conference that there is an established link between Tylenol use during pregnancy and autism. The announcement sought to address "major progress" in autism research and was made in tandem with a number of "bold new...
White Papers, E books, Reports and more

FDA Revises Recommendation for COVID-19 Vaccine

This week, the Food and Drug Administration (FDA) announced that it would revise recommendations for COVID-19 vaccines and boosters going forward, limiting access to people 65 and older or those who are at high risk of becoming seriously ill. In a commentary in the New England Journal of Medicine, FDA Commissioner Marty Makary and...
National News

Trump's Second First 100 Days In Office - Healthcare Impact

The first 100 days of President Donald Trump's second term have been nothing short of eventful across all facets of the healthcare sector. From hirings to firings to rehirings, to unceremonious funding severances, to the appointment of a conspiracy theorist as Secretary of Health and Human Services, the shakeup has been historic and will...
National News

Agency Shakeups Under the HHS Umbrella

Leadership throughout the health agencies continues to fluctuate this week as the Senate affirms new agency heads and longtime career bureaucrats leave amid the turmoil of the Trump administration's onboarding. Last week, the Senate Finance Committee heard testimony from Dr. Mehmet Oz on his vision for the Centers for Medicare and...
National News

FDA to Launch Digital Health Advisory Committee to Debate Artificial Intelligence

Like it or not, generative artificial intelligence (AI) is part of healthcare now. Even though the industry has yet to adequately regulate these tools and the usefulness of large language models in the health care space is still unclear, providers and payers alike are using them in the process of administering care. The Food and Drug...
Trump Wins - Healthcare Industry Braces for Impact Arizona News

Trump Wins - Healthcare Industry Braces for Impact

After Trumps presidential victory, U.S. regulatory agencies should expect shakeups, future ACA Marketplace enrollees could shoulder more premium costs, Medicare Advantage may see a bump in federal enthusiasm and Medicaid beneficiaries may be subject to work requirements. The three-biggest names in Medicare Advantage saw an immediate bump...
Arizona News

Trump, Johnson and Kennedy will 'Blowtorch' the ACA and 'Go Wild on Healthcare!' Harris likes the ACA

Vice President Kamala Harris and former President Donald Trump delivered their final pitches to the American public this week ahead of election day on November 5. Both candidates refined their positions on healthcare policy and the people they'd entrust with health matters should they win the White House. Throughout the campaign...
AI Advances Provide Opportunities for Providers Arizona News

AI Advances Provide Opportunities for Providers

Advances in artificial intelligence (AI) and other tech innovations continue to find applications throughout the medical industry, including in Arizona. As more AI applications enter the biomedical industry, the Food and Drug Administration has investigated how it should go about regulating the programs, platforms and devices that use...
National News

Weight Loss Drugs - Eli Lilly's Ample Supply - Compounders Sue - New Cost Projections

Last week, Eli Lilly announced that the shortage of its landmark weight loss medication Mounjaro was over. This caused a drug compounding industry group to sue the U.S. Food and Drug Administration (FDA). Regardless of the shortage, payers are still wondering how they'll keep up with paying for the expensive GLP-1 treatments. Eli...
National News

SCOTUS Obliterates Agency Interpretation in Two Rulings, Throwing Health Care Administration into Concern

Last Friday, the Supreme Court of the United States (SCOTUS) issued a ruling that will radically curb the ability for the federal agencies to oversee entities as a regulator, which could have a major impact on federal healthcare authorities like the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services...
Featured

SCOTUS Sides With FDA, Rejects Plaintiff Standing in Mifepristone Ruling

Last week, the U.S. Supreme Court sided with the U.S. Food and Drug Administration (FDA) in a case brought by anti-abortion groups seeking to overturn the agency's authorization of the abortion pill mifepristone. The court was united in the decision 9-0. The court ruled that the plaintiffs lacked necessary legal standing to pursue the...
National News

Senators, Nurses Want a Say in Use of AI in Healthcare

While the benefits of generative AI seem obvious for the medical field, regulators and stakeholders are demanding intervention as the new technology sweeps across the industry. Healthcare is unique as a data-driven industry with many potential applications for instant analysis. But as CNBC noted last month, it's also massively...
National News

Experts Concerned Avian Flu May Spread Beyond Dairy Cattle

Avian flu is spreading quickly and has jumped to mammalian hosts, but the response to the looming crisis is worrying some experts. The U.S. agencies responsible for tracking and preventing large scale outbreaks are focusing on the impact the disease may have on the beef and dairy industry, after it was initially found in dairy cows...
National News

One Person, Cattle in Several States Contract Avian Flu

A case of a highly pathogenic avian influenza (HPAI) was confirmed in Texas and in dairy cattle but the Centers for Disease Control and Prevention (CDC), as well as the U.S. Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) are reporting that the risk to the public remains low and they are...
National News

Biden Administration Moves to Protect Contraception, Offers Guidance on EMTALA for 51st Anniversary of Roe v. Wade

This week marks what would have been the 51st anniversary of the Roe v. Wade decision, had it not been overturned by the Supreme Court decision Dobbs v. Jackson Whole Women's Health in 2022. The Biden administration made efforts to highlight advances and protections made in the name of reproductive health by the president to mark the...
CMS Rules

CMS to Relax Rules on PET Scans

The Centers for Medicare and Medicaid Services (CMS) announced this week that it would expand coverage for PET scans used in the diagnosis of Alzheimer's disease. CMS has been hesitant to open reimbursements for the procedure, and the agency has long said that it would only cover one brain scan per beneficiary for a patient's...
COVID-19 Update October 5, 2023 Arizona News

COVID-19 Update October 5, 2023

COVID-19 cases are beginning to subside after a summer spike, but officials are recommending that Americans receive the newly released vaccine or a dose of the newly-authorized Novovax, prior to the expected winter surge in cases. In Arizona, cases were down 5% week over week with 3,134 new cases reported for the week beginning on...
News

New Drug Shortage of Long-Acting Penicillin Is the Most Recent Challenge to the FDA, Supply Chain

Long-acting penicillin, a preferred treatment for syphilis in pregnant women and children, has been added to the list of drug shortages in the U.S. while Arizona currently faces the highest rate of syphilis in newborns. The ongoing drug shortage crisis highlights the limited powers of federal regulators. In June, drug manufacturer...
PwC STUDY: US Health Costs Expected to Rise 7% in 2024 Reports & Surveys

PwC STUDY: US Health Costs Expected to Rise 7% in 2024

A new study by professional services group PwC suggests that health costs are rising quickly and could increase as much at 7% in 2024. To conduct the study, "Medical Cost Trend: Behind the Numbers 2024," PwC surveyed US health plans covering 100 million employer-sponsored members and 10 million Affordable Care Act (ACA) marketplace...
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Region 10 HFMA Webinar: Lunch & Learn with Alan Pruhs, A Discussion on Health Equity January 12, 2026 12:00 PM-1:00 PMMT In a nearly 20-year career as executive director of the Association for Utah Community[...]
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