FDA Law

MARCH 3, 2024

3558 ) on January 25, 2024. This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Scope Part 2 —Is reimbursement under Medicaid a grant of funds by the federal government, such that they are governed by the Act?

Manufacturing 102

Manufacturing Government Consulting IT 102

FDA Law

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. RUO-labeled reagents and materials are often used in LDTs in clinical laboratories. By Steven J.

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IT Manufacturing Government Clinic 64

Physician's Weekly

JUNE 24, 2025

has long disparaged certain vaccines, calling them unsafe and saying that the government officials who regulate them are compromised and corrupt. As data from the 2024-25 season becomes available, researchers hope to determine whether the vaccine will remain a one-and-done, or whether immunity will require repeated vaccination.

Vaccination 52

Vaccination Illness Hospital Patient-Centered 52

ABIM

APRIL 24, 2025

In 2024, 82% of ABIM Board Certified rheumatologists due for an assessment opted for the LKA over the traditional, 10-year MOC exam. Community Practice in ABIM Governance* Dr. Johnson led a discussion with the Rheumatology Board on community practice in rheumatology to create a more inclusive understanding of its role and scope.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

FDA Law

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs). By Steven J.

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Clinic Management Medical IT 59

FDA Law

OCTOBER 7, 2024

2117 (2024). FDA has civil money penalty authority relating to clinical trials, devices, foods, drugs, and tobacco; although with the exception of tobacco, FDA has not recently exercised that authority with regularity. Constitution’s Seventh Amendment right to a jury trial. See SEC v Jarkesy , 144 S. In Huff and Puffers v. filed Sept.

Electronics 59

Electronics IT Government Provider 59

FDA Law

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. an intermediate clinical endpoint) and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

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Clinic Relationship Provider IT 64

FDA Law

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.

Manufacturing 59

Manufacturing Patient-Centered Government Hospital 59

FDA Law

JUNE 16, 2023

Initial appointments to both the Board and advisory council will occur by January 1, 2024. Prescription Drug Affordability Board The law also establishes a nine-member Prescription Drug Affordability Board and an 18-member stakeholder advisory council to provide advice to the Board on drug cost issues.

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Manufacturing Provider Consulting IT 45

FDA Law

JUNE 27, 2024

50,372 , 50,377 (June 13, 2024). The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 21 U.S.C. § 823(g)(1)(B), (D). at 50,376. “A 21 C.F.R. §§ 1306.04(a), a), 1306.06. Code § 64B16-27.810(1).

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Insurance Patients Utilities Chronic Condition 52

ABIM

JUNE 11, 2025

In 2024, 75% of infectious disease physicians who chose an assessment opted for the LKA over the traditional, 10-year MOC exam. Some members of the Specialty Board were interested in the LKA experience, participant survey results—particularly responses about fairness—and how LKA performance data might reflect on clinical outcomes.

Board-Certified 52

Board-Certified Government Community Education 52

ABIM

JUNE 4, 2025

Representatives from the American Association of Clinical Endocrinology (AACE), the Association of Program Directors in Endocrinology, Diabetes and Metabolism (APDEM) and the Endocrine Society joined for a portion of the meeting*. Community Practice in ABIM Governance* Erica N.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

ABIM

MAY 30, 2025

Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. In 2024, 77% of ABIM Board Certified nephrologists due for an assessment opted for the LKA over the traditional, 10-year MOC exam. Community Practice in ABIM Governance* Erica N.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

ABIM

JUNE 24, 2025

In 2024, 78% of hematologists who were due for an assessment and chose to enroll in one chose the LKA over the traditional, 10-year MOC exam, which is on par with the average across specialties. Community Practice in ABIM Governance* Erica N. Most (49.5%) are in single-specialty group practice or multi-specialty group practice (38%).

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

FDA Law

JUNE 9, 2025

These events marked a turning point in expanding representation in clinical studies and opening the door to more personalized medical care. Since 1993, Congress has continued to direct the federal government, and in particular FDA, to take steps to close the gap in clinical research representation.

Clinic 59

Clinic IT Healthcare Medical 59

Medical Xpress

JUNE 16, 2025

This region governs essential behaviors like the circadian clock, sleep, energy balance , and feeding. Po-Ting Yeh, the studys first author, explains the challenge: "It is difficult to study the basic physiological functions controlled by the hypothalamus, which lies deep inside the brain.

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Provider Complication Medical Diabetes 111

FDA Law

MARCH 6, 2025

inpatient hospital, out-patient clinic), date range for the data, and location of the data collection sites (e.g., The DCP should follow applicable regulations governing human subject protections, where applicable. OUS data may introduce bias if the OUS population does not reflect the U.S. data acquisition device).

Manufacturing 105

Manufacturing Management Clinical Practice Clinic 105

FDA Law

MARCH 15, 2023

See Government Accountability Office, “ GAO-06-724 Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations ” (July 2006). The final rule will be effective on September 10, 2024.

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Healthcare Diagnosis Provider Individual 59

FDA Law

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

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Supply Chain Manufacturing Government Hospital 59

GeriPal

JANUARY 11, 2024

A planned expansion of MAID to include people with mental illness was placed on hold until March 2024. ABIM MOC credit will be offered to subscribers in November, 2024. Alex: We’re delighted to welcome Leonie Herx, who’s a palliative care physician and clinical professor at the University of Calgary. Bill: Thank you.

Illness 144

Illness IT Medical Provider 144

GeriPal

APRIL 18, 2024

And I wonder, now, was this 2024 version sort of a redo? And you say, “Okay, that’s fine, but can it really … What about a real live clinical situation?” I think we’re getting closer to real live clinical situations, not just answering a test. That is the first clinical use case.

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Electronics IT Patients Healthcare 139

Medical Xpress

JUNE 7, 2025

The company is working with governments and health groups in the U.K. In clinical trials, no participants who received the injection acquired HIV. But Gilead says the shot should help expand the overall number of people using PrEP in both the U.S. and abroad. © 2025 HealthDay.

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Vaccination Insurance Medical Diabetes 71

GeriPal

DECEMBER 21, 2023

And that’s where, based on this, I made a decision to leave University of North Carolina to come to Indiana University because my mentor, Chris Callahan, just received the grant from AHRQ to build the first randomized clinical control trial that evaluated the comprehensive dementia care model. This is Eric Widera. Diane: Yeah.

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Patient-Centered IT Family Families 125

FDA Law

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

FDA Law

NOVEMBER 18, 2024

Some insights come from an op-ed Kennedy wrote in the Wall Street Journal on September 5, 2024, setting forth some of his plans for a healthier America. Contribution of vaccination to improved survival and health: modelling 50 years of the Expanded Programme on Immunization , Lancet 2024; 403: 2307-16. Andrew J Shattock et al.,

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Appointment Vaccination Patient-Centered IT 116

Physician's Weekly

JULY 2, 2025

Maria is among what the federal government estimates are 2.6 without legal permission — along with the providers and community workers that help them — are anxiously weighing the benefits of pushing forward with Medi-Cal applications against the risks of discovery and deportation by the federal government.

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Community Government Insurance Provider 52

Physicians News Digest

APRIL 17, 2025

including in most states that backed President Donald Trump in the 2024 election. Those changes — plus the firing of 1,200 agency employees as part of mass layoffs across the government — are alarming scientists and NIH workers, who warn that they will undermine progress in combating diseases and other threats to the nation’s public health.

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Vaccination Government Patient-Centered Hospital 52