FDA Law Blog

MAY 9, 2023

We have taken several actions that just in the last few months that have been making sure we’re protecting people’s sensitive information via geolocation data that people can buy to track with great precision” said Khan, “whether people are going to addiction facilities or places of worship or seeking reproductive health service.”

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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. The case law on commission-based marketing agentsincluding the Sorensen decisionfollow in a similar vein.

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Permanente Medicine

MAY 20, 2025

Contributing to this challenge is the exponential growth of information, an expanding population of older adults, and office visit documentation. Information is coming at clinicians, whether they be doctors, nurses, pharmacists, faster than ever, and there is a transparency that exists around us.

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FDA Law Blog

JANUARY 12, 2025

Second, given the potential for reliance upon smaller or shorter clinical trials (than would be typical for traditional approval), there may be less information at the time of approval about rare or delayed adverse events. First, patients may be exposed to safety risks from a drug that subsequently fails to demonstrate clinical benefit.

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FDA Law Blog

SEPTEMBER 6, 2022

Below we outline the Draft Guidance and highlight the new information in the 2022 Draft Guidance. The 2022 Draft Guidance keeps all the same 20 questions with minimal tweaks to wording and added just three new questions and answers. The new Q & As (Q21, Q22, and Q23) all concern charging in the context of expanded access.

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Clinic Manufacturing Patients IT 52

FDA Law Blog

JANUARY 6, 2022

S&G Labs alleged during the litigation that they are paid on a “per test” basis by third party insurers, government agencies under the Medicare and Medicaid programs, and direct “self-pay” by some individuals. S&G Labs has no contractual relationships with the entities that referred clients to S&G Labs. Graves , 2021 U.S.

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FDA Law Blog

JANUARY 6, 2022

S&G Labs alleged during the litigation that they are paid on a “per test” basis by third party insurers, government agencies under the Medicare and Medicaid programs, and direct “self-pay” by some individuals. S&G Labs has no contractual relationships with the entities that referred clients to S&G Labs. Graves , 2021 U.S.

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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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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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Community Individual Mental Health IT 52

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. I felt that I was not able to provide patients with a full discussion of their options to allow them to come to an informed decision, whether due to time constraints or restrictions from administrators.

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Family Physician Family Families Healthcare Professional 52

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. Those are evidence-based or evidence-informed tools that have been in practice.

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FDA Law Blog

JUNE 4, 2025

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

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GeriPal

MARCH 6, 2025

We discuss the principles of harm reduction, social determinants of health, and trauma informed care. By the time he got into us, the tumor grew, he had experienced, he was experiencing significant pain and so trauma, informed care and building a relationship with him was such a big part of the care. On bias and trauma as you.

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Healthcare IT Community Illness 100

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

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.

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Illness IT Medical Provider 144

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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Government Medical Student Community Patients 52

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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Patients IT Patient-Centered Hospital 98

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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Illness Hospital IT Patient-Centered 93

GeriPal

APRIL 18, 2024

It was specific to the relationship with the patient, the patient’s social context in which they might take this information. I don’t need to know how to bill, to enter encounter information to code. Bob: It’s not bad. Alex: That’s pretty amazing. It expressed empathy, it expressed non-abandonment.

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IT Electronics Patients Healthcare 139

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. We’re selling objectivity, information, independence and choice. I knew them, I developed a relationship with them. Take some time to get trust, to get real information.

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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. Its major goal is to try to pull together information on aging and climate change for three groups. Karl: Sure.

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Maine Academy of Family Physicians

JUNE 21, 2024

This bill would preclude the government from charging interest on their loans during when they are unable to afford payments on the principal. Family Physicians Relieved SCOTUS Preserves Patient-Physician Relationship The June 13 U.S. We advocated for the Resident Education Deferred Interest (REDI) Act (HR 1202 / S794).

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Family Physician Family Medicine DO Primary Care 40

GeriPal

AUGUST 22, 2024

Something which draws on some idea of what a human being is, which many of our citizens will disagree with, holding a different philosophical or religiously informed review about that. That also speaks to a lot of the particular family relationships and, of course, in that case, allegations of mistreatment along racial lines and so forth.

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The Clinical Problem Solvers

MAY 2, 2023

Together, our guests explain how trauma shows up in those who experience resettlement, and the role of trauma-informed and culturally-responsive care for refugee, asylee, and immigrant population in clinical practice. This discussion is hosted by Sudarshan Krishnamurthy, Ashley Cooper, and LaShyra Nolen.

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Healthcare Provider Clinical Practice Clinic 52

GeriPal

JUNE 2, 2022

But we have very little information, almost no information. People who had had long standing relationships with their doctors wanted to change doctors. And their death rate was so high during Omicron because they had distrust to the vaccine and distrust to the government. We are going to have a massive outbreak in China.

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FDA Law Blog

MAY 26, 2025

Even if otherwise truthful, the promotion of off-label uses of hormones-including through informal campaigns like those conducted by sales reps or under the guise of sponsored continuing medical education courses-run afoul of the FDAs prohibitions on misbranding and mislabeling. Driehaus , 573 U.S. 149, 158 (2014). See 21 U.S.C.

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