FDA Law Blog

APRIL 23, 2023

Notably, the Draft Guidance states that it is not intended to address other types of external controls, such as using summary-level estimates instead of patient-level data, nor does it discuss the use of external control data to supplement a control arm in a traditional randomized controlled clinical trial. stroke).

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FDA Law Blog

OCTOBER 10, 2023

In the case of 510(k) Implants indicated for use in pediatric patients, FDA recommends consulting two other guidance documents: Pediatrics Guidance and Extrapolation Guidance. Information about these typical non-clinical tests is generally based on previously released guidance documents for each topic, as linked above.

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Manufacturing Engineering Clinic Provider 45

GeriPal

OCTOBER 13, 2022

We have a discussion about the decision to remove race, a social construct, from clinical risk calculators (though I’m not 100% sold that race should always be removed – if removal is likely to worsen disparities for example – at least until a superior race-blind calculator can be developed). difficile infections.

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Complication Patient-Centered IT Patients 97

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? Lastly, I also just want to give a shout out to the last article above which also includes this lovely checklist of methods to address hearing loss in clinical encounters. I’m guessing not. Transcript.

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IT Screening Hospital Clinic 102

GeriPal

DECEMBER 2, 2022

He wrote a book titled “ Psychiatric consultation in long term care ” that has a strengths based approach to staging dementia (how cool is that). She directs UCSF MERI’s patient, family, and clinician support with classes and consultation on resiliency, well-being, and grief. It has to be seen as valued to clinical outcomes.

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Community IT Individual Patient-Centered 101

GeriPal

FEBRUARY 2, 2024

This week, we talk about the other major palliative care trial of default palliative care consults for hospitalized older adults with COPD, kidney disease, or dementia, published in the same issue of JAMA. and consulting for Papa Health. So in this case consultations. Scott: Kate would miss you. laughter] Alex: Yeah.

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Consulting Hospital Patient-Centered IT 120

Today's Hospitalist

JUNE 7, 2025

They presented a rapid clinical update Webinar in May 2025 hosted by the Society of Hospital Medicine. ” All anti-obesity medications, even the earlier generation of these drugs—which include orlistat, phentermine, phentermine/topiramate (Qsymia) and naltrexone/bupropion (Contrave)—cause clinically significant weight loss.

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Hospital Management Diabetes Patients 66

FDA Law Blog

JULY 7, 2024

The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. establish and maintain adverse event files.” [9] 803), Reporting of Corrections and Removals (21 C.F.R. § 820.198). .

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Manufacturing Provider Physicals Electronics 64

GeriPal

OCTOBER 26, 2023

Summary Transcript Summary Often podcasts meet clinical reality. But rarely does the podcast and clinical reality meet in the same day. Ann Henshaw is an occupational therapist who works clinically at Georgetown and teaches at GW. Alex: Today we are delighted to welcome Ann Henshaw who brought this podcast idea to us.

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Patient-Centered Hospital Patients IT 132

GeriPal

OCTOBER 12, 2023

Gretchen: Yeah, I think probably the underlying story here is that I’m really good at doing negative randomized clinical trials, but there is a good thing about doing a big clinical trial, which is that you get tons of data even if you don’t end up with the result that you want. And that’s how we connected.

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IT Family Families Patient-Centered 128

GeriPal

FEBRUARY 15, 2024

And so to them, the real frustrating part is they’re supposed to be treating people like it’s a one-time event the very first time, and the system of EMS is not designed to be longitudinal complex care, and yet that’s basically what we’re seeing happening. I had no idea that people were calling 911 that much sometimes.

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Community Transportation IT PCP 114

GeriPal

OCTOBER 20, 2022

There’s the complications associated with immune senescence, comorbidities, atypical clinical presentations. And I think that’s where this clinical trial which looked at seven versus 14 days was really practice-changing for many of us. difficile infections. difficile that patients are exposed to and antibiotic resistance.

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Complication Patient-Centered IT Patients 52

FDA Law Blog

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). intended use population.

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Clinic Provider Individual IT 59

GeriPal

DECEMBER 5, 2024

It’s that mixture of intimacy and vulnerability, of shared clinical experiences, that fosters a sense of belonging. We definitely draw on the sciences, on biomedical science, on clinical trials, on pharmaceutical design and all sorts of things like that. There’s something magical that happens in small group storytelling.

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IT Community Patients Family 107

GeriPal

JUNE 30, 2022

So when I was a resident at Cleveland Clinic, I got to see really cutting-edge technology, some of the best surgeons in the country, and perhaps in the world, operating on patients. Eric: Let’s say tomorrow, a patient comes into your clinic. Eric: Mm-hmm. Eric: How about you, Samir? Eric: So Samir, you’re a surgeon, right?

Patient-Centered 101

Patient-Centered Complication Patients IT 101

GeriPal

OCTOBER 5, 2023

We need to strike it from our vocabulary and leave sort of a gap in the clinical vernacular about how we talk about life-sustaining treatment. I point this out a lot more nowadays to the resident teams that consult. If the consult is for “code status,” I always ask them, take a look at your past conversations.

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Illness IT Patient-Centered Family 136

GeriPal

MAY 15, 2025

Prior podcasts on the ethics of nudging , and a different trial conducted by Kate and Scott in which the default for hospitalized seriously ill patients was to receive a palliative care consult. The events are conditions that’ll be set into place unless some active choice to the contrary is chosen. What is sludge?

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Patient-Centered Hospital IT Illness 116

GeriPal

MARCH 13, 2025

Alex Smith Links Link to the McGill National Grand Rounds Series on Palliative Care , Michael Kearney as initial presenter, and registration for future events. Michael 45:57 Yeah, I think I would sort of just end by quoting Michael Balint from the Tavistock Clinic in London. Ive got a name. No, you dont need to be Canadian.

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IT Patient-Centered Family Families 104

GeriPal

SEPTEMBER 19, 2024

Eric 07:31 A clinical perspective, why is it important to test this stepped care model versus implementing more? And now when I think about the clinic at Duke, when we’re really running on all cylinders, we can get ourselves up to a five, six, seven week wait for a new palliative care referral. Jennifer 07:31 From.

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Patient-Centered IT Patients Hospital 119

GeriPal

JUNE 22, 2023

Through a series of events, I started working as a consultant to the Department of Corrections in around 2006, and I was assigned to the California Medical Facility. There are clinics. Welcome to the GeriPal podcast, Michele. Michele: Thank you for having me. Michele: Yep.

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Family Families IT Community 132

GeriPal

JULY 25, 2024

Eric 04:39 Yeah, I see it used on inpatient, side on consult clinics in hospices. Eric 07:03 And those classic studies, were those done in the hospital and PALP care units and clinic? The folks that we were seeing either in clinic or inpatient, were probably a lot sicker than the ones that we’re seeing now.

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Family Families Patient-Centered Patients 106

GeriPal

AUGUST 1, 2024

So if you already have a condition, you might be able to prevent events. So I’m hearing, and I’d love to talk about specific diets and maybe the evidence for them, but before we do that, how should we ask about this in our clinics? Eric 18:14 Elizabeth, how do you bring it up in your clinic? Yeah, absolutely.

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IT Diabetes Chronic Disease Patient-Centered 116

GeriPal

NOVEMBER 3, 2022

So people are less able to have the language when the loss event actually happens. And we’ve been really private of doing the research of really doing the deeper thinking about what the loss event happens during the loss event and how we can impact how grief is experienced later. And we don’t talk about it as much.

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Healthcare Professional Healthcare IT Relationship 102

FDA Law Blog

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. In contrast, AMP and ACLA both asserted that the rule would harm medical care.

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Patient-Centered Consulting Government Clinic 102

PEMBlog

MAY 9, 2024

If you have two or more febrile seizures, you have a 50% chance of subsequent events. Well, they say that LP should be performed when there are meningeal signs or symptoms or other clinical features that suggest possible meningitis or intracranial infection. Simple febrile seizures do not require neurology consults or admissions.

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Illness Vaccination Family Families 59