FDA Law

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

DECEMBER 13, 2023

GeMDAC was established to advise FDA regarding treatments under the purview of CDER’s Division of Rare Diseases and Medical Genetics (DRDMG), within the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine. Note that FDA is currently soliciting applications to staff this committee.

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PEMBlog

APRIL 20, 2023

Emicizumab (Hemlibra) was approved in 2018 for routine bleeding prophylaxis in hemophilia A with or without inhibitors. It is therefore no hyperbole to say that Emicizumab has been a life-changing therapy for individuals with hemophilia A who have factor VIII inhibitors (alloantibodies against factor VIII). This is a black box warning.

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FDA Law

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

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

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FDA Law

JUNE 29, 2022

The Expedited Programs Guidance describes situations warranting rescission as when emerging data no longer support the BTD, another product gains traditional approval and evidence is not provided that the designated drug may demonstrate substantial approval over the approved product, or when the program is no longer being pursued.

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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

APRIL 3, 2022

The prior BOP regulations became effective April 1, 2018, requiring owners to report the loss of any controlled substance, even single doses, to the Board. Injectable multidose injectables, infusion medications or unidentified other multi-dose unit-two or more multi-dose vials, infusion bags or other containers.

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FDA Law

JUNE 23, 2021

As someone who studied in the fields of public health, medical sociology, and biomedical ethics, I was impressed with how quickly the pharmaceutical and biotechnology arena caught up with what took many decades to occur in the context of the physician-patient relationship.

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FDA Law

FEBRUARY 27, 2024

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. 2018) , Arnold Partnership v. See Lourie, Patent Term Restoration: History, Summary, and Appraisal, 40 Food, Drug, and Cosm.

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FDA Law

SEPTEMBER 20, 2021

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs.

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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 22, 2025

These included how well physicians demonstrated respect, listened to individuals, explained information, and spent enough time with them. Similarly, listening was rated lower (β = −0.286, 95% CI = −0.391 to −0.181, P = 0.001), as were explanations provided by clinicians (β = −0.133, 95% CI = −0.267 to −0.000, P = 0.050).

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FDA Law

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. Then, in 2016, FDA noted its goal to streamline MDR requirements in the Medical Device User Fee Amendments of 2017 (MDUFA IV) commitment letter.

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The Clinical Problem Solvers

FEBRUARY 8, 2023

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. These narratives have vilified individuals who would benefit from comprehensive, person-centered substance use treatment, rather than incarceration and other adverse harms.

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FDA Law

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

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. I think, as providers, we don’t get to see that.

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FDA Law

JUNE 24, 2021

Cato — On June 18th, FDA published a draft guidance document titled Remanufacturing of Medical Devices , which has been several years in the making. In 2016, FDA opened a docket seeking comments on “service, maintenance, refurbishment, and alteration of medical devices” by third parties (see our blog post here ). By McKenzie E.

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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. Emmy: But we know that physiologic changes with aging, like decreasing night vision and so forth, as well as medications, as well as medical conditions, can all affect whether you can drive. Weren’t those the days?

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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

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. Although, certainly when you start facing complications of serious illness, it is increasingly important to engage as individuals and conversations about goals, values, and preferences.

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GeriPal

AUGUST 17, 2023

So what is the role of individuals like geriatricians in prescribing amyloid antibodies and caring for individuals who are receiving them? And I do think geriatricians need to as individuals make that decision, largely based on their comfort with the diagnostics and the specifics of the therapeutics. I’m a prescriber.

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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. Annie 02:31 So if you go to the A G S meeting every year, you know that this group of three individuals comprises the AGS literature update. Alex joined in 2018.

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GeriPal

APRIL 24, 2025

And so this term was developed by our group to capture either non traditional therapies or really conventional medical therapies that patients may be pursuing with little hope of reaching a goal of care and significant risk. Eric 06:58 It could be CPR in an individual with metastatic cancer in the icu. Did I say that correctly?

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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. So for primary care providers, you order that blood test, you own that.

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GeriPal

MAY 12, 2022

Raj: It was indeed very, very gradual, and the seeds were sown when I was a medical student. So, we formed this organization called Pain and Palliative Care Society in the Northern Kerala city of Kalakkad based in the government medical college. Raj: That’s one of the high tech medical absurdities that we have developed.

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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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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, more trust develops.

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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

MARCH 27, 2025

But most people with dementia are initially diagnosed and medically managed in primary care, and they really desire clinicians to initiate these conversations but there are a number of really important barriers for these conversations taking place. And is it at all individualized to the patient? It’s a great question.

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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. About 40% of adults with HIV rely on it for their lifesaving treatments.

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FDA Law

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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Physicians News Digest

APRIL 3, 2025

Survey data gathered by AHRQ provides much of what is known about hospitalizations for motor accidents, measles, methamphetamine, and thousands of other medical issues. Medical errors caused by missed diagnoses, drug errors, hospital infections, and other factors kill and maim tens of thousands of Americans each year.

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