FDA Law Blog

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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FDA Law Blog

NOVEMBER 6, 2022

In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.” 2011), here , and United States v. Borrasi, 639 F.3d

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FDA Law Blog

SEPTEMBER 15, 2024

The PREVAIL Act In short, the PREVAIL Act is intended to, among other things, reform the Inter Partes Review (“IPR”) process created by the 2011 Leahy-Smith America Invents Act. This in turn can allow generic and biosimilar companies to launch their products sooner, providing patients with earlier access to more affordable medications.

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FDA Law Blog

MAY 3, 2021

DEA seeks to prevent, detect and eliminate the diversion of controlled pharmaceuticals while ensuring their availability for legitimate medical, scientific and industrial purposes. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

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FDA Law Blog

JULY 24, 2023

Specifically, FDA determined that Avadel’s Lumryz can “break” Jazz’s ODE because it is “clinically superior” based on Lumryz’s “major contribution to patient care,” rendering it not “the same drug” under the Orphan Drug Act. Avadel has intervened as a Defendant, and neither FDA nor Avadel has yet to respond to the Complaint.

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FDA Law Blog

MAY 3, 2021

DEA seeks to prevent, detect and eliminate the diversion of controlled pharmaceuticals while ensuring their availability for legitimate medical, scientific and industrial purposes. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

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Management Manufacturing Specialization IT 40

Medical Xpress

JUNE 16, 2025

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GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. It’s not a controlled substance medication. Tasce: Yes. Taylor Swift.

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Medical Xpress

JUNE 16, 2025

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GeriPal

JANUARY 16, 2025

These individuals may become unrepresented, meaning they lack the capacity to make a specific medical decision, do not have an advance directive for that decision, and do not have a surrogate to help. We’re going to be talking about the American Geriatric Society position statement on making medical treatment decisions.

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Patient-Centered IT Patients Healthcare 109

GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . Zachary: I mean, I did my med school and residency training in Louisville, Kentucky, and I had a second year med student lecture from Joe Rotella who was, I think the chief medical officer at Hospices at the time.

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GeriPal

DECEMBER 8, 2022

Clinicians “catching” patient life stories. . Our patients aren’t “the 76 year old with heart failure in room 202,” as Heather Coats astutely noted. Storytelling Helps Hospital Staff Discover The Person Within The Patient. Eric’s blog post on Dignity Therapy from 2011. Because that really is what this is about.

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GeriPal

NOVEMBER 2, 2023

Alex: Today we’re delighted to welcome Jerry Gurwitz, who is a geriatrician and professor of medicine at the UMass Chan Medical School. I talked about lack of prestige and respect, and I talked about how healthcare system leaders and medical school deans don’t always seem to value the field of geriatrics. How long ago?

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The Medical Futurist

JUNE 17, 2025

Ettinger, who died in 2011, went on to found the Cryonics Institute in Michigan where he, his mother and his first and second wives all now reside in metal flasks kept at −196 °C. However, The Medical Futurist is not sure whether a form of deep sleep will be enough if we want to travel light years.

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GeriPal

DECEMBER 15, 2022

Along the way we address: Is this degree of slowed cognitive decline meaningful to patients or care partners? Eric: So patient narrative storytelling, independent of what we call it, I’d like to turn to both of you and just how you got interested in this as a subject. She was a heart failure patient.

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IT Patient-Centered Healthcare Illness 105

GeriPal

APRIL 13, 2023

But, should we as clinicians care about the social lives of our patients? Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? We’ll talk about is it in medical practice yet? Eric: You’ve timed it perfectly. It came after engaging her.

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IT Community Patient-Centered Medical 99

PEMBlog

JUNE 5, 2024

Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. 2011 Aug;58(2):145-55. The most common injuries seen in these younger patients are growth plate fractures and ligamentous injuries. MMWR Recomm Rep. 2012 Jan 13;61(RR-1):1-20. PMID: 22237112. Ann Emerg Med.

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Medical Xpress

JUNE 8, 2025

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GeriPal

MARCH 16, 2023

Rosanne: I think I was motivated by the number of times patients asked me to get rid of their pot-bellies, quite honestly. So I felt like over all these years I have learned so much from my patients and from the science, that it should be out there in one place where people can easily access it and help themselves. Eric: Yeah.

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IT Healthcare Professional Healthcare Transportation 105

GeriPal

JULY 7, 2022

And then one day when I was in my third year of medical school, I was in the gym and I hurt my back in a really horrific way. I was helped into a wheelchair kind of rushed to the emergency room, which was not far away because I was on the medical school campus. I thought I couldn’t finish medical school.

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Medical Xpress

JUNE 7, 2025

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GeriPal

DECEMBER 1, 2023

In particular we spend a good deal of time talking about what this means for asymptomatic patients who may have an abnormal biomarker, which by the proposed new definition would mean they would now have Alzheimer’s disease. Eric: Wonderful. Jason: A bit of an irony there is that Simple Minds is the band. laughter] Heather: Good point.

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Medical Xpress

JUNE 8, 2025

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Medical Xpress

JUNE 23, 2025

Other factors including humidity, wind and peoples ages and medical conditions play a role in heat illness as well, Wood says. When he worked on a medical mission in Haiti, he got used to seeing people wrap their heads in water-soaked towels and throw ice down their groin. 40°C (101–104°F).

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Illness Engineering Nurse Practitioner Medical 53

PEMBlog

APRIL 4, 2025

I asked some ID experts and we haven’t broadly assessed our rate, and we could do this, but it would take really a manual query of state vaccine records for any patient that doesn’t have vaccine status in the EMR. of their patients were fully vaccinated, five and a half percent were under vaccinated, and 3% were unvaccinated.

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Physicians News Digest

APRIL 1, 2025

Elberg said considerable fraud in Medicare and Medicaid exists largely because the programs’ “pay-and-chase models” prioritize paying for patient care first and tracking down stolen dollars second. Patients could be tested as little as once a year or as often as monthly depending on their level of risk, according to the DOJ lawsuit.

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