FDA Law Blog

FEBRUARY 28, 2023

FDA announced on October 3, 2022 that the voluntary electronic Submission Template And Resource (eSTAR) templates would be required beginning October 1, 2023, as we blogged about here. There are two forms: one for non-IVD devices and one for IVD devices. The same forms are used for both 510(k)s and De Novo submissions.

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Provider Electronics IT Complication 52

Mesa Family Physician

MARCH 6, 2025

Identifying health concerns before symptoms appear gives us tremendous advantages in treatment success and minimizing long-term complications. Many practices now offer electronic pre-registration that can be completed before your appointment. Many healthcare systems provide electronic access to this information through patient portals.

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Preventive Care Preventative Care Appointment Screening 100

Medical Xpress

JUNE 16, 2025

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Food and Drug Administration (FDA). The process could take years. Ibogaine is made from the root of a plant found in Africa. It has been banned in the U.S. Former Texas Gov.

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Mental Health IT Medical Specialization 52

Medical Xpress

JUNE 16, 2025

But what we observed was much more complicated." This cluster of about 20,000 to 40,000 neurons functions like a central watch, coordinating the timing of body functions to follow the 24-hour day. When we cross time zones and experience jet lag, it happens because our internal clock remains set to the old time zone.

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Provider Medical Complication Diabetes 109

GeriPal

SEPTEMBER 7, 2023

Summary Transcript Summary The comprehensive geriatric assessment is one of the cornerstones of geriatrics. But does the geriatric assessment do anything? Does it improve outcomes that patients, caregivers, and clinicians care about? We talk about: What is a practical geriatric assessment and how can busy oncologists actually do one? Thank you.

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Patient-Centered IT Patients Clinic 130

GeriPal

JUNE 15, 2023

Audio: [electronic voice] Alex Smith has been taken over by an artificial intelligence. Hallucinations, or when the AI lies or b *s, then denies it When the AI approaches sentience, is it ethical to unplug it? I’m sure this is a subject we will return to, given the rapid progress on AI. This is Eric Widera. Who are you going to be talking to?”

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IT Patient-Centered Patients Healthcare 100

GeriPal

JUNE 30, 2022

Should she have an operation, and risk the pain, potential complications, and attendant delirium associated with the operation? You have a patient with dementia severe enough that she cannot recognize relatives. She falls and breaks her hip. Should she be treated non-operatively, with aggressive symptom management? It was Remember Me.

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Patient-Centered Complication Patients IT 101

GeriPal

JULY 21, 2022

Because I don’t think we think about that so much in palliative care, but we do in geriatrics. But I believe before we start, somebody has a song request for Alex. Is it you, Emmy? Emmy: It is. Eric: What’s the song? Emmy: I just forgot the name of the song… [laughter]. Alex: Pink Cadillac by Bruce Springsteen? I like that song.

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IT Families Family Diagnosis 102

GeriPal

OCTOBER 19, 2023

Summary Transcript Summary What level of evidence do we need for POLST to use it ourselves, to advocate for wider usage, and for establishing POLST completion as a quality metric? The answers to these questions will vary. Reasonable people will disagree. And today, on our podcast, our guests disagree. But is it a tiny, meaningless, fraction?

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Patient-Centered IT Patients Illness 127

GeriPal

MAY 15, 2025

The nudge toward offering comfort care led to more hospice and early comfort-care orders. Is this due to chance alone, given the multiplicity of secondary outcomes examined? We’ve done a podcast already on nudging. Where was it? Alex 01:13 The nudging podcast We’ve done a couple I think. We also had a podcast with. Eric 02:08 Great.

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Patient-Centered Hospital IT Illness 118

GeriPal

APRIL 10, 2025

I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. They got training in Vital Talk and ELNEC. They got feedback. So did it matter? Fernanda 01:16 I do have a song request.

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Patient-Centered IT Hospital Patients 78

GeriPal

MARCH 28, 2024

Kate: So it was an embedded alert in the electronic health record and they just clicked those two answers very quickly. I’m just stunned even writing that! We’ve come so far as a field. This is Eric Widera. Alex: This is Alex Smith. Eric: Alex, who do we have with us today? Were you at the GeriPal pub crawl? laughter] Eric: 2:30 AM.

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Consulting Patient-Centered Patients IT 116

GeriPal

JULY 28, 2022

Jennifer’s study is most widely known for the “kicker” – not only did it improve quality of life, palliative care was associated with a couple months longer survival. . Areej’s study is remarkably novel in that it is, to our knowledge, the first study of palliative care during curative treatment. . Alex: (singing). Areej: Wow.

Illness 111

Illness Hospital Patient-Centered Patients 111

GeriPal

JUNE 9, 2022

How do we move from efficacy (works in highly controlled settings) from effectiveness (works in real world settings? What’s the role of implementation science? What is a pragmatic trial ? What outcomes should we measure? We cover a lot of ground! Working on a mystery. Going wherever it leads. “Runnin down a dream…” -@AlexSmithMD.

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Consulting Patient-Centered Diagnosis IT 100

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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Patients IT Patient-Centered Hospital 98

FDA Law Blog

MAY 21, 2024

Public comments must be submitted electronically or postmarked on or before July 22, 2024, 60 days after publication in the Federal Register. DEA explained that “the lack of consistent concentrations” of delta-9-THC and other substances in marijuana complicates the effects of different constituents within marijuana. 21 U.S.C. §

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Physicals Medical Clinic Emergency Room 69

GeriPal

MARCH 27, 2025

We are delighted to welcome Jennifer Wolf f , who is a health services researcher and gerontologist and professor at Johns Hopkins. Jennifer, welcome to the GeriPal Podcast. Jennifer 00:28 It’s great to be here. But before we dive into the study and the implications it has for the practice that we do, I believe someone has a song request.

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Primary Care IT Clinic Patient-Centered 80

GeriPal

FEBRUARY 24, 2022

Since then there has been a lot of back and forth, with even a couple of podcasts from us, several JAMA viewpoints, and most recently a series of published replies from leaders in the field on why ACP is still valuable (see below for references). . Despite all of these publications, I’m still left at a loss of what to think about it all.

Illness 98

Illness Patient-Centered IT Patients 98

Physician's Weekly

JUNE 17, 2025

Prior authorization mostly happens behind the scenes, almost always electronically, and nearly all requests are quickly, or even instantly, approved. He weighed 97 pounds and wasn’t expected to survive a year with stage 4 cancer. But chemotherapy has also ravaged Tennant’s body and his quality of life. Senate report.

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Insurance Patients Behavioral Health Services Diagnose 52