FDA Law Blog

JULY 17, 2022

An example of such a drug is a single-use vial of an injectable cancer drug that is dosed based upon weight, and therefore might not be entirely used for a lighter weight patient. On July 8, as part of its annual physician fee schedule update for 2023, CMS issued a proposed regulation to implement the new refund.

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FDA Law Blog

MAY 30, 2024

The 340B statute requires drug manufacturers to sell certain drugs at discounted ceiling prices to covered entities, which are defined by statute to include certain types of safety net hospitals, health centers, and clinics receiving federal grants. District Court and won, prompting a government appeal to the D.C.

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FDA Law Blog

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. More updates will follow here as trends develop in 2023. Combination products might be part drug, part device, or part software or hardware.

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PEMBlog

MAY 24, 2023

Patient that are agitated should always be treated with dignity and respect. Marianne Gausche-Hill New England EMSC: New England Regional Behavioral Health Toolkit Disclaimer The Emergency Medical Services for Children Innovation and Improvement Center is supported by the Health Resources and Services Administration (HRSA) of the U.S.

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GeriPal

SEPTEMBER 5, 2024

And Bill Andereck is still haunted by the decision he made to have the police break down the door to rescue his patient who attempted suicide in the 1980s, as detailed in this essay in the Cambridge Quarterly of HealthCare Ethics. And he’s also chaired the California Pacific Medical Center’s ethics committee since 1985.

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GeriPal

MARCH 6, 2025

So we did a podcast on aging and homelessness with Margot Kushel in 2023. They’re more, more interested in relationship centered care than the fancy medicines that you’re. And I wonder if that is key in patients, people who are experiencing homelessness as well. Government is not the 51st state.

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GeriPal

AUGUST 15, 2024

Ongoing reports from patients about anti-Asian hate experiences Should clinicians screen for Anti-Asian hate? This question, while providing an opportunity to talk about direct and indirect experiences, can be asked of all patients, and opens the door to conversations about anti-semitism, islamophobia, or anti-Black racism.

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GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Care Ecosystem.

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Common Sense Family Doctor

APRIL 25, 2025

While I'm grateful for subspecialists who alleviate pain, rescue patients who are unable to breathe on their own, manage complicated fractures, and replace worn-out hips and knees, the gap between the number of family doctors we need and the number we have keeps getting wider. This is where the federal government must step up.

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Physician's Weekly

JUNE 26, 2025

He directed the patients to seek local help. While it’s possible that Nath’s patients suffered covid vaccine injuries, Marks said, their symptoms were so varied it was hard to characterize a possible syndrome. centers study rare vaccine reactions. His clinical study was ending. Kennedy Jr. forced him out in May.

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Physician's Weekly

JUNE 13, 2025

Sheps Center for Health Services Research following a request from Senate Democrats, who released the findings publicly Thursday. Iowa, Texas, and Minnesota had the most rural obstetrics service closures between 2011 and 2023, according to the health analytics and consulting firm Chartis , which also studies rural hospital finances.

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GeriPal

JULY 20, 2023

Clinicians could care for patients across state lines, could prescribe opioids without in person visits, could bill at higher rates for telemedicine than previous to the pandemic. Many patients benefited, not only those isolating due to covid, but also patients in rural areas, patients who are homebound, and many others.

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FDA Law Blog

NOVEMBER 18, 2024

He states, correctly, that PDUFA user fees make up about 75% of the budget for the Center for Drug Evaluation and Research (CDER). Though he did not mention it, there is also a Medical Device User Fee Act (MDUFA), which accounted for approximately 44% of the budget for the Center for Devices and Radiological Health (CDRH) in FY2023.

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Physicians News Digest

APRIL 3, 2025

The episodes turned both women into advocates for patients and spurred research that made American health care safer. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals. It also has published tools and guidelines to enhance patient safety.

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Physicians News Digest

APRIL 17, 2025

in 2022, according to the Centers for Disease Control and Prevention. Harm to HIV, Vaccine Studies The NIH, with its nearly $48 billion annual budget, is the largest public funder of biomedical research in the world, awarding nearly 59,000 grants in the 2023 fiscal year. Now those places aren’t immune to the NIH’s terminations.

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