Physician's Weekly

JUNE 24, 2025

Robin Wolaner, 71, a retired publisher in Sausalito, California, has been known to badger friends who delay getting recommended shots, sending them relevant medical studies. has long disparaged certain vaccines, calling them unsafe and saying that the government officials who regulate them are compromised and corrupt. Kennedy Jr.,

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PEMBlog

MAY 31, 2023

However, medications can be adjuncts to non-pharmacologic means to help keep agitated children safe from harm. Government. When we think of managing agitated patients we think of medicines – but that shouldn’t be our first option. It is also episode 3 in a 5 episode series focused on agitation in children and adolescents.

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FDA Law Blog

OCTOBER 8, 2023

Palmer — On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlled substances, which were originally set to expire after the end of the COVID-19 pandemic emergency. By Karla L. comments on the two proposed rules.

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FDA Law Blog

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C.

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FDA Law Blog

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. Any application from a State or Federal Government entity. Exemptions or Waivers.

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PEMBlog

MAY 17, 2023

Why then do we persist with the “is it medical/organic or psych” question? Government. Most children who present to Pediatric Emergency Departments these days with mental health concerns – including agitation – have a known psychiatric problem or diagnosis.

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PEMBlog

JUNE 14, 2023

This episode is a co-production of the Emergency Medical Services for Children Innovation and Improvement Center whose mission is to minimize morbidity and mortality of acutely ill and injured children across the emergency continuum. Government. Pediatrics March 2023; 151 (3): e2022057383. Coker, Gretchen J. Morse, Katherine A.

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FDA Law Blog

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. The pandemic also deeply impacted how industry and the government conduct their operations. The pandemic also deeply impacted how industry and the government conduct their operations.

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FDA Law Blog

MAY 19, 2025

For a controlled substance prescription to be effective, that is valid, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. Attorneys Office, Northern District of Illinois, April 21, 2025. Complaint, 82. 81, 86, 251.

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FDA Law Blog

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 812(c)(c)(10). 21 U.S.C. §

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FDA Law Blog

JANUARY 5, 2023

In mid-November, FDA collaborated with the MITRE Corporation to publish an update to the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. Combination products are sharing the digital moment with those classified solely as medical devices. More updates will follow here as trends develop in 2023.

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FDA Law Blog

MARCH 3, 2024

The LDT rule has moved forward with astonishing speed, advancing from the release of the proposed rule on October 3, 2023 to OMB in less than five months. Given that Congress struggles to keep the government funded, it is far-fetched now to expect Congress to enact this complex legislation – especially since it has repeatedly failed to do so.

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FDA Law Blog

SEPTEMBER 17, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. Inside Building 66 Upon arriving at Building 66, all visitors must present government-issued photo identification for check-in.

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FDA Law Blog

MARCH 24, 2024

The federal government has long maintained that state law offers an additional, and important, layer of consumer protection that complements federal regulation. According to the court, “[j]ust because a medication is subject to multiple legal requirements does not make it impossible to comply with Act 1103.

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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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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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FDA Law Blog

AUGUST 17, 2022

Legally marketed devices that do not need a new 510(k) must comply with these regulations by April 14, 2023. The preemption provisions, for example, have not changed.

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ABIM

MAY 30, 2025

Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. One notable trend was a higher representation of international medical graduates and osteopathic physicians in the specialty. Community Practice in ABIM Governance* Erica N.

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Medical Xpress

JUNE 16, 2025

This region governs essential behaviors like the circadian clock, sleep, energy balance , and feeding. The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. But technical limitations have made it hard to understand how neurons in this area form functional circuits."

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FDA Law Blog

OCTOBER 17, 2023

Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction. By Philip Won & Lisa M.

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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. We desperately need real medical support.”

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PEMBlog

MAY 24, 2023

Government. For more information, please visit HRSA.gov To learn more about the Emergency Medical Services for Children Innovation and Improvement Center visit [link] Email km@emscimprovement.center Follow on Twitter @EMSCImprovement References Berzlanovich AM, Schöpfer J, Keil W.

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FDA Law Blog

APRIL 8, 2024

the focus of the paper turns back to “drug shortages” generally, but HHS acknowledges that “shortages of medical devices have also been an issue for many decades.” HHS suggests that its proposed HRSP “could be expanded to the outpatient setting or to include medical devices.” What about government factors that cause drug shortages?

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FDA Law Blog

NOVEMBER 21, 2024

DEA notes in the Federal Register notice that it received over 38,000 comments to its 2023 proposed rules (35,454 for the general telemedicine flexibilities proposed rule and 2,915 for the buprenorphine telemedicine flexibilities proposed rule), and held two days of public listening sessions addressing industry comments.

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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. The preamble notes that this information would help ensure that drugs are being used for approved or otherwise medically accepted indications.

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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. Reading Ira’s article, it essentially was the VITAS Medical Director job description.

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GeriPal

MARCH 6, 2025

link] Toronto Star Feature [link] CityNews Toronto Feature [link] Psychosocial Interventions at PEACH In addition to medical care, PEACH also runs two key psychosocial interventions for our clients: PEACH Grief Circles Structured spaces for workers in the homelessness sector to process grief. those experiencing homelessness).

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GeriPal

SEPTEMBER 29, 2022

Eric and I are working on it…maybe by 2023? . Janet Abrahm is a Professor of Medicine at Harvard Medical School and Dana-Farber Cancer Institute, and the Department of Psychosocial Oncology and Palliative Care. And yes, this would be a great one for CME. AlexSmithMD. Transcript. Eric: Welcome to the GeriPal Podcast!

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GeriPal

SEPTEMBER 5, 2024

And he’s also chaired the California Pacific Medical Center’s ethics committee since 1985. Louise 05:02 Yes, well, I don’t know about 2024, but in 2023, yes, it could happen. But one of the things I worry about, when we really know medically where this case is going and we find, how many times has this happened?

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FDA Law Blog

AUGUST 14, 2022

Inflation rebates under Medicare Parts B and D: Starting in 1Q 2023, mandatory quarterly rebates will be imposed on manufacturers of single-source drugs and biologics covered under Part B that have price increases exceeding the rate of inflation. The same will be required under state Medicaid and CHIP programs by October 1, 2023.

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FDA Law Blog

FEBRUARY 11, 2024

We blogged on the December 5, 2023, letter from six Democratic governors to President Biden). The former officials implore following the science demonstrating marijuana’s high addictive potential, its lack of accepted medical use, and the rescheduling impact on prosecuting drug trafficking organizations. Letter to U.S.

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FDA Law Blog

JANUARY 24, 2024

Fast-forward to March 2023, when The White House OSTP issued a document per Executive Order 14081, titled “ Bold Goals for U.S. And so in November 2023 in St. The robust discussion that day in November 2023 is now captured in an APIIC report announced this week , titled “ A Bold Goal: Reshoring 25% of Small Molecule API to the U.S.

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GeriPal

AUGUST 15, 2024

We discuss: What is considered a hate incident, how is it tracked, what do we know about changes over time The wider impact of Anti-Asian hate on older Asians, who are afraid to go out, leading to anxiety, social isolation, loneliness, decreased exercise, missed appointments and medications. Eric 14:41 You mentioned the study.

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GeriPal

APRIL 20, 2023

In the United States in 2023, the truth of the matter is you don’t need very many individual risk factors to become homeless. In what moral universe is a federal government deeply subsidizing my housing and not subsidizing that of my patients? What medical intervention saves health dollars, costs less than not doing it?

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GeriPal

DECEMBER 21, 2023

But for other- Diane: And it’s on the medical side. Just to let you know, Eric, we have to give the credit to our federal government. Some of these models I think include more medication management, some of them don’t. Malaz: … they have to do medication management. Diane: Yeah. Malaz: Yeah.

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Common Sense Family Doctor

APRIL 25, 2025

population, and a near-doubling in outpatient visits to advanced practice providers (the majority of whom work in medical subspecialties) wasn't enough to make up for this deficit. I'm an example of this pattern, having intended to become a pediatrician when I started medical school.) This is where the federal government must step up.

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Physician's Weekly

JUNE 12, 2025

In a 2024 report covering the years 2022, 2023, and 2024, Medicaid’s parent agency — the Centers for Medicare & Medicaid Services — said the rate was about 5.1%. Other experts told PolitiFact that the actual numbers could be higher than what the federal government reports, although not as high as Paragon’s estimate.

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