FDA Law Blog

OCTOBER 30, 2022

This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance document. FDA intends to incorporate these updates into the December 2018 Breakthrough Devices Program guidance after considering public comment.

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The Clinical Problem Solvers

DECEMBER 16, 2020

Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality. These factors include a high-protein diet, muscle mass, creatinine generation, and certain medications. link] Tsai J.

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FDA Law Blog

MAY 2, 2022

Marijuana is legal for medical use in 37 states, and for recreational use by adults in 18 states, but the drug remains a federal schedule I substance. In response to states authorizing and legalizing marijuana while it remained a schedule I substance federally, Deputy Attorney General James Cole provided guidance in a memorandum to U.S.

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FDA Law Blog

FEBRUARY 27, 2023

The Ryan Haight Act was enacted to address the legal “grey area” in which prescribers and pharmacies operated via the creation of two new statutory requirements: 1) the at least one “in-person” medical evaluation requirement for prescribing practitioners, 21 U.S.C. § 829(e); and 2) the modified registration requirement for online pharmacies.

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FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

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FDA Law Blog

JUNE 23, 2021

Janet Woodcock’s leadership, identified the need for more systematic patient engagement — a way to improve representativeness and be more proactive rather than reactive to interacting with patient communities. So, we crafted the Patient-Focused Drug Development, or PFDD, a commitment that was agreed to in PDUFA V.

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GeriPal

JUNE 8, 2023

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. Our last podcast was with Laura Petrillo in 2018 – 5 years ago seems ancient history – though many of the points still apply today (e.g. How high is too high?

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FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

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GeriPal

OCTOBER 24, 2024

David is a physician who wrote the book “ Stoned: A Doctor’s Case for Medical Marijuana ” and gave a TED talk on “ A Doctor’s Case for Medical Marijuana ” that was watched over 3 million times. laughter] Alex 01:39 Material here for songs related to medical marijuana or marijuana in general. Eric 01:34 Yeah.

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BMJ

FEBRUARY 8, 2021

Two out of three drug overdose deaths in 2018 involved an opioid – be it prescription opioids, heroin, or synthetic opioids. 6 As a result of these and many other actions, the death toll from opioid overdose fell by more than 4% between 2017 and 2018. misuse of prescription medications). 3 To respond to this crisis, the U.S.

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Physician's Weekly

JUNE 19, 2025

Pregnant with her second child, she schleps a backpack instead of a traditional black bag to carry a laptop and essential medical supplies — stethoscope, blood pressure cuff, and pulse oximeter. “We step into places where other providers may not, and geriatrics is a prime example of that.”

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The Clinical Problem Solvers

FEBRUARY 8, 2023

Identify realistic solutions to drug policy reform that promote health equity among marginalized communities living in the United States. Screening for substance use and offering connections to treatment and community-based services are important strategies that clinicians can implement in their own practice today.

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GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. And yet, after assisting the older adult to their feet, the EMS providers would leave. So Carmen and Katie developed an EMS Community Partnership program.

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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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GeriPal

MARCH 2, 2023

JAMA Surgery 2018 Gabapentin and mood stabilizers in the Nursing Home Setting: Antiepileptic prescribing to persons living with dementia residing in nursing homes: A tale of two indications. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? J Am Geriatr Soc.

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GeriPal

JUNE 22, 2023

Summary Transcript Summary In the early 1990’s, California Medical Facility (CMF) created one of the nation’s first licensed hospice units inside a prison. Alex: We are in the California Medical Facility and we will ask our guest about that. I’ve known Michele a long time, since the Joint Medical Program. Michele: Yep.

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GeriPal

MAY 12, 2022

Prognosis communication and the subtle ways we may communicate it without intention. Community-based palliative care networks . Raj: It was indeed very, very gradual, and the seeds were sown when I was a medical student. Raj: That’s one of the high tech medical absurdities that we have developed.

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GeriPal

JULY 21, 2022

Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. But then once it was open, started seeing a lot of other populations: not just our own hospital population, but a lot more just community members calling with concerns about driving. Weren’t those the days? Eric: Yeah.

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GeriPal

SEPTEMBER 7, 2023

William: So ASCO decided to make a high priority this year to redo the guidelines, which were originally released in 2018. And because, it’s a little kid in a candy store, so many different choices for quote, unquote, “community oncologists,” and perhaps even for academic oncologists. Throw it in the trash.”

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FDA Law Blog

MAY 16, 2024

UMHS agreed to resolve the allegations in August 2018 for $4,300,000 and compliance with a three-year Memorandum of Agreement (“MOA”). The tech’s husband distributed the drugs in the community. Controlled substances are a necessary component in hospitals providing needed medical care to patients.

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GeriPal

APRIL 3, 2025

We covered: The first parody song I wrote, for AGS 2018 in Orlando , about this article by Nancy Schoenborn on how to discuss stopping cancer screening. Alex joined in 2018. This was 2018 in AGS Orlando, and they did a song about when to stop screening for cancer for colon cancer. Alex 05:15 Oh, really? And so we did this song.

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GeriPal

MARCH 24, 2022

2018 Systematic Review of Systematic Reviews on ACP. And I don’t think necessarily, that appointment needs to be a medicalized process. And I would say too, as a primary care provider, it really doesn’t take that long to ask people about a surrogate decision maker. Alex: What did it changed to after 2018?

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Illness IT Healthcare Patient-Centered 73

GeriPal

FEBRUARY 6, 2025

We have two new FDA-approved medications that reduce that amyloid buildup and modestly slow down the progression of the disease. He is associate professor at the University of Wisconsin and medical director of their Alzheimer’s Disease Research Center. It’s not on the community’s end. Great to be back.

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Family Medicine Initiative

APRIL 10, 2024

Family medicine is neither the most prestigious nor the highest paid medical profession. Having Your Own Long-Term GP Can Save Your Life Patients who choose a GP rather than a specialist as their primary care provider have a 19% 8 lower mortality and produce 22% 9 -33% 8 lower healthcare spending. Over time, communication improves.

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GeriPal

MARCH 3, 2022

I want to say like 2017, 2018, something like that. I think there’s so much more, that’s known now about Alzheimer’s and out in the general public, hopefully providers are having these conversations, but we can’t really take too much comfort in it because of those findings that you just mentioned by John Tino.

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Patient-Centered Patients IT Hospital 96

GeriPal

OCTOBER 3, 2024

I was on a retreat with Guy Micco , who’s been on this podcast several times, and he was teaching a class on death while I was in medical school. What is it about the images of the dying that helps teach medical students? And dying is too big, too profound for any one model, including the medical model.

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GeriPal

APRIL 21, 2022

We talk not only about reading poetry, but also writing poetry, and using poetry in medical education as a healing modality. To the deeper emotions – of loss and grief, of wonder and transcendence – that are at the heart of the complex care we provide. And along the way, we really felt like we got to the heart of things.

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GeriPal

MARCH 27, 2025

The reason I chose this song is because I’m currently working on bringing advanced care planning sessions to the Latino community. In our planning sessions, one of the biggest barriers to advanced care planning in this community is just talking about death. Why did you even bother doing this study? It’s a great question.

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Primary Care IT Clinic Patient-Centered 80

Pamela Wible MD

JUNE 19, 2025

Published 2/5/19, updated 6/19/25) Rowdiest audience ever (at a medical conference at least). It’s now so common that more than half of all doctors report symptoms, with medical students , residents , and even senior clinicians feeling pushed to the brink. Among medical trainees suicide is the number one cause of death today.

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Physician's Weekly

JUNE 17, 2025

GLP-1 agonist medications Ozempic, Wegovy, and others also are delivering dramatic results for millions. For example, up to 15% of patients in the GLP-1 trials didn’t respond to those drugs, and at least one study found the medications didn’t significantly help Prader-Willi patients. Kennedy Jr.

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PEMBlog

DECEMBER 4, 2024

This episode also covers what healthcare providers need to know about post-exposure prophylaxis, respiratory precautions, and managing occupational exposures. Pediatr Rev May 2018; 39 (5): 247–257. Non medical exemptions accounted for over 93 percent of these exemptions. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

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Physician's Weekly

JUNE 25, 2025

Dangerous changes loomed: To compensate for tax cuts for the wealthy, Trump’s “big, beautiful” bill and budget proposal for fiscal year 2026 threaten to curtail Medicaid, which provides health coverage for people with low incomes and disabilities. “But I am grateful that I am part of a community that will not bow down.”

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FDA Law Blog

JUNE 23, 2024

The CSA and regulations promulgated by DEA are intended to reduce the potential for diversion and abuse and ensure that controlled substances are dispensed and delivered to patients for a legitimate medical purpose. However, TDD medications are highly concentrated opioids and cannot be self-administered. 2] Why is this an issue?

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