FDA Law Blog

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Mallory , 988 F.3d 3d 730 (4th Cir. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th Polin , 194 F.3d

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FDA Law Blog

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Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J.

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FDA Law Blog

SEPTEMBER 6, 2022

As the new Federal Register notice explains, FDA issued the 2016 Guidance in question and answer format to respond to the most frequently asked questions about charging for investigational drugs provided under an IND for either clinical trials or expanded access for treatment use under 21 CFR section 312.8. Changes from the 2016 Guidance.

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FDA Law Blog

JANUARY 6, 2022

Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added).

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FDA Law Blog

JANUARY 6, 2022

Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added).

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Annals of Family Medicine

NOVEMBER 20, 2024

Objective To evaluate public perceptions of uncertainty and disagreement among experts in healthcare recommendations and whether it is associated with decreased trust in health entities as providers of accurate health information. Only 18% have high trust in the health information on social media.

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ABIM

JUNE 4, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. Community Practice in ABIM Governance* Erica N. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations.

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Vida Family Medicine

JUNE 29, 2022

I care deeply about each and every one of my patients, and I do not want a difference in opinion to create a wedge in our relationship. The healthcare system must provide care in a just way so that those who need care have access to it. When I was a medical student at Baylor College of Medicine, I participated in their Ethics track.

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The Clinical Problem Solvers

FEBRUARY 14, 2022

By preventing Black and Brown people from developing relationships with the land and using it as a way of forming social connection, as well as communal sustenance, structural racism manifests along lines of race and place. The vision for any community-informed project has to meet community members where they are. What are their needs?

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FDA Law Blog

MARCH 13, 2024

1.740), stating that: If the applicant for patent term extension was not the marketing applicant before the regulatory agency, then there must be an agency relationship between the patent owner and the marketing applicant during the regulatory review period. They all as for the same type of information: U.S. Namely, Biogen MA Inc.

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GeriPal

JANUARY 20, 2023

Jasmine: It’s an imaginative love story that deconstructs age through an intergenerational friend relationship. There have been multiple subsequent government reports on nursing home care, most recently was about eight, nine years ago from the OIG. So I am requesting The Sifters by Andrew Bird. Eric: Can I ask why?

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GeriPal

JUNE 19, 2025

Just today (June 17th) as we record this podcast: Ezra Klein released a wonderful interview with Sarah McBride , the first openly transgender member of congress A judge ruled that cuts to NIH grants focused on minority groups, including transgender people, were illegal and ordered the government to restore funding.

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Individual Community IT Chronic Condition 81

GeriPal

MARCH 6, 2025

We discuss the principles of harm reduction, social determinants of health, and trauma informed care. link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. What we hear is that it is more trauma informed in many contexts to have people first language.

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GeriPal

JANUARY 11, 2024

** Claim your CME credit for EP293 “What’s Up With MAID in Canada” [link] Note : If you have not already registered for CME, you can register here [link] For more info on the CME credit, go to [link] Disclosures: Moderators Drs Widera and Smith have no relationships to disclose. AMA PRA Category 1 credit(s) ™. Eric: Yeah.

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Doctors for America

MAY 5, 2025

FOR IMMEDIATE RELEASE Doctors for America PO Box: 21161 2300 18th St NW Lbby Washington, DC 20009-9996 May 5, 2025 Doctors, Local Governments File Brief to Defend Reproductive Health Care Privacy Rights Brief Argues that Upending HIPAA Privacy Rights Would Contradict Decades of Established Precedent WASHINGTON, D.C.

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GeriPal

SEPTEMBER 5, 2024

And it’s not the same, but it does provide information. Eric 42:11 But how much of it is like Winston Churchill, like, democracy is the worst form of government. Widera and Smith have no relationships to disclose. Guests Louise Aronson and Bill Andereck have no relationships to disclose. Bill 42:22 I did not.

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GeriPal

JUNE 26, 2025

And the government can do something about that?!? And there is this bidirectional relationship between wealth and health shocks. And then I was inspired by this paper and then really interested in looking at the bidirectional relationship between the two of them. So still we have this bidirectional relationship.

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GeriPal

JULY 6, 2023

I’ve been on a quest to build those services and support so that people can make true, informed decisions for themselves and their families. It was designed to really balance what Medicaid at the time was to provide nursing homes and Medicare is obviously health insurance. Susan: Yeah, I don’t think the word even surfaced.

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Community Nurse Practitioner Provider IT 89

GeriPal

DECEMBER 7, 2023

So if you look at government websites about heat for example, it’s got a line of buttons across the top with affected populations, outdoor workers, athletes and older people are in there. What do we do to very concretely provide heat shelters and cool shelters?

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Healthcare IT Education Community 129

Maine Academy of Family Physicians

JUNE 21, 2024

Providers of abortion and gender affirming care in Maine are effectively shielded from laws in other states by the passage of protection by the legislature. This bill would preclude the government from charging interest on their loans during when they are unable to afford payments on the principal. LD 227 was signed by Governor Mills.

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Family Physician Family Medicine DO Primary Care 40

GeriPal

AUGUST 22, 2024

Healthcare provide. They’re often the ones who are most directly in touch with a grieving family or may have their own concerns about the care that’s being provided and the worth or value of what they’re showing up and doing every day. Eric 10:35 Are there others, the people who need the organs? Insurance companies.

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The Clinical Problem Solvers

MAY 2, 2023

[link] CPSolvers: Antiracism in Medicine Series Episode 21 – Psychosocial and Cultural Considerations for Providing Healthcare to Immigrant and Refugee Populations Show Notes by Kiersten T. This discussion is hosted by Sudarshan Krishnamurthy, Ashley Cooper, and LaShyra Nolen.

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GeriPal

JUNE 2, 2022

But we have very little information, almost no information. And then maybe KN95s, FFP2s and KF94s, if you wear them, at least in physical science studies, if you’re inside in a crowded where Warrior stadium or something, that should provide you some self protection. We are going to have a massive outbreak in China.

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FDA Law Blog

MAY 26, 2025

Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care. Department of Health & Human Services purporting to provide a comprehensive review of the evidence and best practices for promoting the health of children and adolescents with gender dysphoria.

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