FDA Law Blog

MARCH 29, 2024

In 2022, the Government Accountability Office reported that FDA needed to improve its foreign inspection program. These are BIMO inspections of hospitals, clinical research organizations (CROs), and other similar facilities where clinical trial work is performed. But gaps still remain. The vast majority are for drugs.

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Clinic IT Manufacturing Government 59

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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Manufacturing Patient-Centered Government Hospital 59

FDA Law Blog

JANUARY 5, 2023

The current Team Lead for Injection Devices in CDRH’s Division of Drug Delivery and General Hospital Devices and Human Factors noted that depending on the product, the pre-market path for a connected combination product might require an IND, IDE, or a determination that it is a medical device data system , which are not regulated as devices.

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Patient-Centered Manufacturing Provider Telehealth 59

FDA Law Blog

SEPTEMBER 12, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

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Hospital Government Patients 49

FDA Law Blog

SEPTEMBER 26, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

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Hospital Government Patients 45

Physician's Weekly

JUNE 23, 2025

MONDAY, June 23, 2025 (HealthDay News) — The National Institutes of Health (NIH) will fund studies of the long-term health effects of a 2023 Ohio train derailment that released more than 1 million pounds of hazardous chemicals into the soil, air and water.

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Community Asthma Engineering Complication 52

FDA Law Blog

APRIL 8, 2024

To address the underlying causes of shortages, the White Paper suggests that the creation (by Congress) of two programs that link inpatient hospital purchasing and payment decisions to supply chain resilience practices would better incentivize investments in mature manufacturing practices. surgical robots, MRIs)? Section I.C

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Supply Chain Manufacturing Government Hospital 59

PEMBlog

MAY 24, 2023

Government. Department of Health and Human Services (HHS) as part of an award (U07MC37471) totaling $3M with 0 percent financed with nongovernmental sources. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S.

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Management Patient-Centered Physicals Finance 54

FDA Law Blog

OCTOBER 17, 2023

By Philip Won & Lisa M. FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations.

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Medical Diagnosis Healthcare Clinic 53

GeriPal

MARCH 6, 2025

Michaels Hospital in Toronto, and health justice activist. Michael’s Hospital in the Department of Family and Community Medicine. So we did a podcast on aging and homelessness with Margot Kushel in 2023. You know, we found that 64% of the people we cared for never went to the hospital or ER.

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Healthcare IT Community Illness 100

GeriPal

MARCH 24, 2023

JAMA IM 2023 A shout-out to my NPR episode on 1A titled the “State of Hospice Care” DISCLAIMER While we filmed in Montreal during the Annual Assembly, all opinions expressed in this podcast are independent of AAHPM and HPNA, or the Annual Assembly. (singing) Ira: Thank you very much. JAMA Health Forum. Most of the time it works out.

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IT Provider Patients Families 113

GeriPal

SEPTEMBER 5, 2024

He had a 14 month recovery in hospital and rehab and continually asked to have life sustaining treatment suspended so that he could be allowed to die. Louise 05:02 Yes, well, I don’t know about 2024, but in 2023, yes, it could happen. She didn’t die in the hospital. A farmer nearby came to. I’m gonna die.

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Patients IT Patient-Centered Hospital 98

GeriPal

APRIL 20, 2023

Today we talk with Margot Kushel about how we got here, including: That sense of powerlessness as a clinician when you “fix up” a patient in the hospital, only to discharge them to the street knowing things will fall apart. We would admit them to the hospital. Who doesn’t want to leave the hospital?

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Mental Health IT Community Individual 123

GeriPal

DECEMBER 21, 2023

The way we were treating him with dementia in the hospital, the way we talked about him, that he’s not there. Malaz: … to restrain them in the hospital. You come over to the clinic, you go to the hospital, you provide service, and the insurance and you negotiate how much you’re going to get paid.

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Patient-Centered IT Families Family 125

Common Sense Family Doctor

APRIL 25, 2025

Before becoming a core faculty member at the Lancaster General Hospital Family Medicine Residency Program , I spent more than 15 years teaching in Georgetown's family medicine department. This is where the federal government must step up. But we need more research to design and implement these efforts.

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DO Family Medicine Family Families 52

Physician's Weekly

JUNE 13, 2025

Cuts to Medicaid and other federal health programs proposed in President Donald Trump’s budget plan would rapidly push more than 300 financially struggling rural hospitals toward a fiscal cliff, according to researchers who track the facilities’ finances. “People will die” if rural hospitals close, he said.

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Finance Hospital Community Emergency Room 52

The Clinical Problem Solvers

MAY 2, 2023

“Gillette” Gillette-Pierce May 2, 2023 Summary: This episode highlights the psychosocial and cultural considerations for providing healthcare to immigrant and refugee populations. Opinion: Covid-19 Shows Us Why We Should Keep ICE Out of Hospitals. April 25, 2023 Show Transcript Download CPSolvers App here RLRCPSOLVERS

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Healthcare Provider Clinical Practice Clinic 52

GeriPal

JULY 20, 2023

See the AAHPM Legislative Action Center [link] Write to the DEA, with guidance from AAHPM’s comments to the DEA March 2023. If you look at just the latest statistics in terms of how many hospitals have a dedicated palliative care service, it’s increased and grown over time. Start with a story as Carly did in her Op Ed.

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Telemedicine Telehealth Patient-Centered Board-Certified 73

Physician's Weekly

JUNE 25, 2025

In the 1980s, the government refused to acknowledge HIV as gay men died young. Gaunt and feverish, he went to the hospital and learned he had AIDS. His mother slept at his hospital bedside for two weeks: “She said, ‘God got you.’” “I thought my family was going to disown me,” he said.

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Government Community Families Family 52

GeriPal

APRIL 17, 2025

I think it was the 2023 World Series where Dusty Baker faced off as the manager of the Houston Astros against David Roberts. Now to the federal government that is going way beyond what I think people truly understand. And there was never a federal government shutdown during the Obama administration. Well played.

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IT Community Government Management 70

Physician's Weekly

JUNE 27, 2025

Nursing homes have struggled to replace licensed nurses, who can find better-paying jobs at hospitals and doctors’ offices, as well as nursing assistants, who can earn more working at big-box stores or fast-food joints. In 2023 he moved into one of the skilled nursing small houses, where Conteh started caring for him.

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Community Internal Medicine Families Family 52

Physicians News Digest

APRIL 3, 2025

Helen Haskell’s 15-year-old son, Lewis, died after surgery in 2000 because weekend hospital staffers didn’t realize he was in shock. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals.

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Patient-Centered Hospital Diagnose Medical 52

Physicians News Digest

APRIL 17, 2025

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. In November 2023, he told an anti-vaccine group, “I’m gonna say to NIH scientists, ‘God bless you all. Thank you for public service.

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Vaccination Government Patient-Centered Hospital 52