PEMBlog

JUNE 14, 2023

Government. Pediatrics March 2023; 151 (3): e2022057383. Characteristics, Clinical Care, and Disposition Barriers for Mental Health Patients Boarding in the Emergency Department. Department of Health and Human Services (HHS) as part of an award (U07MC37471) totaling $3M with 0 percent financed with nongovernmental sources.

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Mental Health Management Patient-Centered Illness 98

FDA Law Blog

OCTOBER 7, 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. If FDA is prohibited from pursuing the relatively small dollar value tobacco penalty cases administratively, it could affect enforcement.

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Electronics IT Government Provider 59

FDA Law Blog

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. § 355(i)(1)(A). 42 U.S.C. §

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Clinic IT Utilities Government 64

FDA Law Blog

MARCH 1, 2023

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. By Holly N.

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Management Manufacturing Supply Chain Provider 45

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

Another is the June 2022 Letter to Health Care Providers about a cybersecurity vulnerability affecting Illumina medical devices for clinical diagnostic use in sequencing a person’s DNA or testing for various genetic conditions. More updates will follow here as trends develop in 2023.

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Manufacturing Patient-Centered Provider Telehealth 59

FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

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Provider Screening IT Government 59

FDA Law Blog

JUNE 27, 2024

After issuing an Order to Show Cause and Immediate Suspension of Registration in September 2022, and an administrative hearing in March 2023, DEA adopted the hearing Administrative Law Judge’s (“ALJ’s”) Recommended Decision to revoke Coconut Grove’s registration based on the public interest factors of 21 U.S.C. 21 U.S.C. § 823(g)(1)(B), (D).

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Insurance Patients Utilities Chronic Condition 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. Of note, the findings so far indicate that 90% of nephrologists who responded are clinically active. Community Practice in ABIM Governance* Erica N.

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Board-Certified Government Internal Medicine Private Practice 40

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 Medical Complication Diabetes 109

FDA Law Blog

OCTOBER 17, 2023

This implies that if device technologies and features can produce a clinically meaningful impact for the treatment or diagnosis of a condition in certain populations, such data could support the case that the device satisfies the first designation criterion. By Philip Won & Lisa M.

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Medical Diagnosis Healthcare Clinic 53

FDA Law Blog

APRIL 8, 2024

What about government factors that cause drug shortages? What the White Paper does not adequately address is whether there are any government-controlled factors that also cause drug shortages. We recently summarized another GAO report which described challenges FDA continues to face with clinical research inspections.

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Supply Chain Manufacturing Government Hospital 59

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. It was statistically significant, but not all of it was clinically meaningful.

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IT Provider Patients Family 113

FDA Law Blog

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. These, at least, are deserving of comments, which are due by July 25, 2023.

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Manufacturing Vaccination Government Diagnosis 59

GeriPal

SEPTEMBER 29, 2022

Hypnosis: uses and how to get training via the American Society of Clinical Hypnosis. Eric and I are working on it…maybe by 2023? . I’ll have to share with you my clinical experience and my reading of the literature. Lidocaine: worth the hype? Strengths and weaknesses of buprenorphine for cancer pain. AlexSmithMD.

Management 101

Management IT Patients Family 101

GeriPal

APRIL 20, 2023

I would talk about this, except I was a clinician, and I’m seeing these folks in the hospital and in clinic. The journal section’s requirements are the same as for a clinical investigation. In the United States in 2023, the truth of the matter is you don’t need very many individual risk factors to become homeless.

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Mental Health IT Community Individual 123

GeriPal

AUGUST 15, 2024

It’s both institutionalized racism where there are policies and practices by corporations, by government that create inequality. Really, across the board, there was a spike, and it seemed to have, seems to have come down from 2022 to 2023. We do a lot of clinical focused discussions. It’s still obviously quite there.

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Mental Health Community Screening IT 116

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. ” Diane: Fantastic. Diane: Yeah.

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Patient-Centered IT Family Families 125

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. This discussion is hosted by Sudarshan Krishnamurthy, Ashley Cooper, and LaShyra Nolen.

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Healthcare Provider Clinical Practice Clinic 52

Physician's Weekly

JUNE 26, 2025

His clinical study was ending. In 2001, the CDC set up the Clinical Immunization Safety Assessment project, through which a network of eight U.S. ” Nath published an article in 2023 calling for more investigation of vaccine-related neurological conditions. He directed the patients to seek local help.

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Vaccination Patient-Centered Government IT 52

FDA Law Blog

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

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. ” And I could tell you that’s a lot for a government agency to hear. If I have a clear referral in that’s two physicians agreeing this patient should be in my clinic and considered for opioids.”

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Telemedicine Telehealth Patient-Centered Board-Certified 73

FDA Law Blog

NOVEMBER 18, 2024

Referencing an interview with Kennedy from 2023, the Post says that his views on health “were a head-scratching spaghetti of what we can only call warped conspiracy theories, and not just on vaccines.” Wise government officials will modulate their views as they learn new facts. To some degree.

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Appointment Vaccination Patient-Centered IT 116

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. Alex 20:58 Farah, appreciate the medicine metaphor for our clinical audience. Well played.

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IT Community Government Management 70

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