FDA Law Blog

OCTOBER 8, 2023

That First Temporary Rule also provided a one-year grace period, through November 11, 2024, for any practitioner-patient telemedicine relationships established on or before November 11, 2023. DEA next hosted Telemedicine Listening Sessions on September 12 and 13, 2023, for which it receive over 180 requests to present. 69,879, 69,880 (Oct.

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The Physicians Foundation

FEBRUARY 14, 2025

Along with tracking the health of primary care, the Scorecard provides progress updates on the NASEM report’s policy recommendations for federal and state governments, health care organizations, and payers. Key findings include: 1. health spending, with spending on Medicare falling to 3.4% and Medicaid to 4.3%. per 100,000 in 2022.

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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. Medicare or Medicaid). OIG reviews non-safe harbored arrangements on a case-by-case basis. In contrast to its decision in United States v. Polin , 194 F.3d 3d 863 (7th Cir.

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Permanente Medicine

MAY 20, 2025

” Related AI scribes story: Analysis: AI scribes save physicians time, improve patient interactions and work satisfaction Dr. Nguyen also highlighted the potential to utilize artificial intelligence and Kaiser Permanente’s extensive medical database to develop predictive analytic models aimed at enhancing patient care.

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Tiny Physician

JULY 3, 2022

The use of this remedy as per homeopathic textbooks is to break down emotional barriers and boost relationships. If this is true, then the North and South Korean leaders should have this simultaneously in order to improve relationships between them. Yeah, you heard it right, moon.

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FDA Law Blog

MAY 9, 2023

The news wasn’t all bad for the government, but FTC’s now has some decisions to make. But the judge also dealt a blow to the government, dismissing its suit against Kochava. So, the government here has a choice to make. Kochava decided to strike first and sued the FTC , hoping to preempt the pending enforcement suit.

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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. FDAs application and use of accelerated approval has evolved dramatically since it was first developed by the Agency to help address the HIV/AIDS epidemic in the late 1980s.

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The Clinical Problem Solvers

AUGUST 25, 2020

Pearls Defining Structural Racism Structural racism is a term that acknowledges that racism is perpetuated beyond individual interactions and interpersonal racism, but is present in the systems and policies that govern our everyday lives.

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FDA Law Blog

JUNE 8, 2023

The pandemic also deeply impacted how industry and the government conduct their operations. By following these tips, industry may be able to foster a productive and constructive engagement with FDA, leading to favorable outcomes for the development of new medical products and a strengthened relationship going forward.

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FDA Law Blog

SEPTEMBER 6, 2022

For example, the Draft Guidance includes answers to general questions about the intended timeframe for response to charging requests (30 days), who should request FDA’s authorization to charge (the IND sponsor), and whom the sponsor may charge with this authorization (not FDA’s business).

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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. 18 U.S.C. §

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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. 18 U.S.C. §

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Annals of Family Medicine

NOVEMBER 20, 2024

Main Outcomes and Measures Trust in different experts, doctors, scientists and government health agencies for health information. Results There was high trust in doctors as sources of health information is 95% while 84% had high trust in scientists and only 70% in government health agencies.

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ABIM

JUNE 4, 2025

Community Practice in ABIM Governance* Erica N. She also sought input on overlapping aspects of community practice across the disciplines of internal medicine to inform ABIM’s recruitment efforts for broad physician representation in governance roles.

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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. Funding structures, especially from government agencies, are not exactly permissive of this. Be curious.

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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. Can you tell me about that?

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GeriPal

JANUARY 20, 2023

Jasmine: It’s an imaginative love story that deconstructs age through an intergenerational friend relationship. Jasmine: It’s an imaginative love story that deconstructs age through an intergenerational friend relationship. Welcome back to the GeriPal podcast, Mike. I hope I got that right. Mike: You got it right.

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GeriPal

MAY 12, 2022

Raj faced in pain management: access to opioids, corruption, a system that doesn’t see addressing suffering as a priority. Prognosis communication and the subtle ways we may communicate it without intention. Social pain and loneliness. Community-based palliative care networks . Raj’s reflections on the state of palliative care in the US. Transcript.

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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. However, this particular decision infringes on my ability to practice medicine ethically, so I feel it is important for me to respond.

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Doctor Rachel

FEBRUARY 17, 2019

This is a HUGE subject and this is a brief attempt to organize my early thoughts on right relationship, through the lens of my own life. Marriage and relationship, certainly. Doug suggested that the connection between these topics is Right Relationship. To be in Right Relationship with self, with others, and with nature.

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GeriPal

APRIL 13, 2023

I initially got into it because I was really looking at the psychophysiology of stress, and so how stress affects our health and how relationships were always a component of that. Welcome back, Ashwin. Ashwin Kotwal: Excited to be back. Eric: Now, it’s interesting. Was hoping to hear Hey, Ya by OutKast. Alex: Great. All right.

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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. must demonstrate its agency relationship with the NDA holder (Biogen, Inc.)

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GeriPal

MARCH 6, 2025

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. Today we discuss: What is the best terminology? Homelessness? Marginally housed? What makes it rewarding? Naheed 03:48 Yeah, for sure.

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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

JANUARY 11, 2024

Panelists Bill Gardner, Sonu Gaind, Leonie Herx have stated they have no relationships to disclose. Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). Four percent. To many this rapid expansion will represent autonomy run amok. It is the slippery slope made real. It was amazing.

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Tiny Physician

MARCH 30, 2022

A doctor-patient relationship is mandatory in the case and this can be proven by cross-checking the duty list or from the patient’s case sheet. Direct causation There has to be a direct relationship between the damage and the breach of duty. Her previous delivery (twins) was conducted at the same hospital itself.

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GeriPal

SEPTEMBER 5, 2024

But before we go into all of that, I think, Bill, you have a song request for Alex. Bill 01:52 I do. Bill 01:53 Alex asked me for a song that was resonating in my head at the time, and it would be Guy Clark’s song, T he Cape. Eric 02:01 Why guy Clark’s the Cape? Bill 02:03 Oh, it’s a long story. I’ll make sure. Here we go.

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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

APRIL 18, 2024

We discuss, among other things: Findings that in several studies AI was rated by patients as more empathetic than human clinicians (not less, that isn’t a typo). Turns my concern about lack of empathy from AI on its head – the AI may be more empathetic than clinicians, not less. ” Eric: What was it called again, Wachter’s World?

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GeriPal

JUNE 26, 2025

And the government can do something about that?!? Tsai-Chin’s article, published in Lancet Healthy Longevity, found a tantalizing hint that countries with stronger safety nets had lower incidence of wealth shocks, and less of a deleterious impact of the wealth shock on cognitive function. This is Eric Widera. Alex 00:12 This is Alex Smith.

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GeriPal

DECEMBER 7, 2023

Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US. My kids ask – why don’t adults care about this issue the same way that they and their friends care about it? Ruth: Thank you.

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GeriPal

JULY 6, 2023

Summary Transcript Summary You may have heard of Area Agencies on Aging, but do you really know what they do or how they do it? What about State Departments of Aging or state master plans for aging? Do you know how these agencies fit in with programs like Meals-on-Wheels or other nutritional support programs? Susan: It is my anthem.

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GeriPal

AUGUST 22, 2024

Why does this issue keep coming up? Why is it unresolved? Today we put these questions to Winston Chiong, a neurologist and bioethicist, and Sean Aas, a philosopher and bioethicist. We’ll have a link to that in our show notes. We’re gonna double up on that subject. Alex 01:07 We haven’t figured it out. Alex 01:48 All right.

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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. Here in Maine the "shorter" Legislative Session was quite full!

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The Clinical Problem Solvers

MAY 2, 2023

Hayat discusses the five major waves of migration in the last fifty years, resulting from the Soviet-Afghan War, the Afghan Civil War, the Fall of the Taliban, August 2021 US and western forces departure, and how he grew up during the 1990s right after the collapse of the government.

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GeriPal

JUNE 2, 2022

Well, on today’s podcast we invite Monica Gandhi to sum up the evidence to date about how best to prevent getting COVID (or at least the severe outcomes of the disease) and how to treat it, including the role of Paxlovid in symptomatic disease. A good twitter criticism of the CDC 1 in 5 COVID survivors have long COVID study. Transcript. Alex: Great.

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FDA Law Blog

MAY 26, 2025

Below, we highlight some of the challenges we would see in the governments attempt to pursue these cases. Late last month the Attorney General issued a memo addressing both directives. First, it direct[s] all U.S. MedImmune, Inc. Genentech, Inc., 118, 129 (2007) (quoting Abbott Labs v. Gardner , 387 U.S. 136, 152 (1967)). See United States v.

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