FDA Law Blog

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. There are hundreds of known genetic metabolic diseases, most of which are rare and carry significant morbidity.

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FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.

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Clinic IT Provider Patient-Centered 59

33 Charts

OCTOBER 2, 2021

According to Epic, the number of patient messages spiked 151 percent nationally from the period covering the first 11 weeks of 2020 through the end of the year. The zero-sum medical day In many healthcare systems the Epic feature is turned on and health professionals are expected to respond. COVID has clearly driven remote care.

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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. What are the risks and rewards of new classes of medications? When I’m on nursing home call, the most common page I receive is for a blood sugar value. How high is too high?

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Diabetes Management Patient-Centered Family 73

FDA Law Blog

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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GeriPal

JANUARY 12, 2023

Alex: And we’re delighted to welcome back to the GeriPal Podcast, Stephanie Rogers, who’s a geriatrician and medical director of UCSF’s, age-friendly health systems. And those that are out there in this space tend to be grouped together in academic medical centers. Kellie, welcome to the GeriPal Podcast.

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Hospital Patient-Centered IT Nurse Practitioner 100

Medical Xpress

JUNE 16, 2025

But what we observed was much more complicated." The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. The traditional model is simple: SCN neurons were believed to act like runners in a relay race, passing the light signal along in a linear chain. What are the consequences?

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Provider Complication Medical Diabetes 109

Medical Xpress

JUNE 16, 2025

The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. Learn more Your name Note Your email address is used only to let the recipient know who sent the email. Neither your address nor the recipients address will be used for any other purpose. What are the consequences?

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Mental Health IT Specialization Medical 52

The Clinical Problem Solvers

FEBRUARY 8, 2023

Pearls: In 2020, American Indian and Alaska Native (Indigenous) communities experienced the highest drug overdose mortality rate of any racial or ethnic group, also surpassing rates among the non-Hispanic white population. Once the need for labor was largely met, anti-Chinese narratives (e.g.,

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Community Patient-Centered Mental Health Board-Certified 52

GeriPal

JANUARY 25, 2024

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. It used to be a much more complicated model. These were general medical nurses or social workers. David: Thank you. David: Right.

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GeriPal

MARCH 30, 2023

We’ve also love to hear from you on twitter and facebook your own experiences writing for the medical world (and please include links!) And so, it’s about going live on stage in the medical audience, and everything from the whiteboard in the surgery room saying, “Here’s the lineup. This is Eric Widera.

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IT Patient-Centered Patients Healthcare 95

GeriPal

OCTOBER 19, 2023

And we have Scott Halpern, who is Professor of Medical Ethics and Health Policy and Director of the Palliative and Advanced Illness Research Center or Payer Center at the University of Pennsylvania. So now it’s just POLST, the word POLST, Portable Medical Orders. Hey, it’s National POLST Collaborative now. Good to know.

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Patient-Centered IT Patients Illness 126

GeriPal

MAY 26, 2022

First we have Emily Largent who is a bioethicist in the Department of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine, welcome to the GeriPal podcast, Emily. Eric: And Alex, who do we have on the show with us today? Alex: Today, we are delighted to welcome two bioethicists. Emily: I do.

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GeriPal

FEBRUARY 8, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. 2023.11.004.

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GeriPal

OCTOBER 26, 2023

Within hours of recording this podcast, I joined a family meeting of an older patient who had multiple medical problems including cancer, and a slow but inexorable decline in function, weight, and cognition. But rarely does the podcast and clinical reality meet in the same day. Very excited to be here. Tamra, welcome to the GeriPal podcast.

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Hospital Patient-Centered Patients IT 132

GeriPal

APRIL 10, 2025

Do they have documents in the record like medical orders for life sustaining treatment or a healthcare proxy? Yeah, that’s a more complicated story. But yeah, it’s complicated. Remember, this was March 2020, around that time when we got all this training and we were having now these conversations really often.

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Patient-Centered Hospital IT Patients 77

Family Medicine Initiative

APRIL 10, 2024

Family medicine is neither the most prestigious nor the highest paid medical profession. You no longer need to review all medical records or repeat the whole medical and personal history. Adherence to medical advice improves and unnecessary self-referrals to other doctors decrease. Over time, more trust develops.

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Family Physician Family Families GP 130

GeriPal

FEBRUARY 13, 2025

But again, hindsight’s 2020 probably wasn’t the best measure to look the other one we tested in an exploratory way was feeling heard and understood. We gave these tools to oncology and fusion room N that was complicated. So absolutely, it is complicated. We’ve looked at that in a couple of different ways.

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Consulting Community Patient-Centered Family 63

FDA Law Blog

JUNE 21, 2022

Back in the 2017 user fee package, the FDA Reauthorization Act (also called “FDARA”), Congress set forth a process for establishing a category of OTC hearing aids—hearing aids that may be sold directly to patients without the intervention of a medical provider. We are approaching 5 years since Congress directed FDA to issue the OTC rules.

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IT Provider Government Patients 52

GeriPal

NOVEMBER 3, 2022

Alex: And we’re delighted to welcome back to the GeriPal podcast, friend of the pod, Craig Blinderman, who’s Director of Adult Palliative Care Services and Associate Professor of Medicine at Columbia University Irving Medical Center. Welcome back to the GeriPal podcast, Craig. Craig: Thanks so much, Alex and Eric.

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Tiny Physician

OCTOBER 17, 2021

Indian Medical Association (IMA) Kerala wing criticized the minister at that time as the medicine lacked scientific evidence (2). However, there is no clinical trial on its effect on COVID 19 infection or its complications. The talks around this remedy hibernated for a year, but the latest order by GoK reopened the same chapter.

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GeriPal

SEPTEMBER 14, 2023

2020 Hospital at Home-Plus: A Platform of Facility-Based Care. The pneumonia could get treated, but I think geriatricians, actually, were well aware of iatrogenic complications of care and quality gaps, even well before the IOM reports of the late 1990s and the like. That started in November of 2020. Annals of Int Med.

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FDA Law Blog

OCTOBER 14, 2022

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “We still have a problem with COVID. The President’s comments caused us, who work in the medical product industry, to wonder how the federal government officially declares an end to the Covid-19 public health emergency. We’re still doing a lot of work on it.

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GeriPal

JUNE 2, 2022

it was April, 2020. We’re actually lower of COVID deaths in this country than we’ve ever been since March of 2020. I’ve really looked into this because I partially feel responsible for masks because I wrote this article in March of 2020, and it was being reviewed. It was that day that I was totally deflated.

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Vaccination IT Hospital Management 100

GeriPal

JULY 16, 2024

Eric Widera reminds us of the history of the Goldwater Act created by the American Psychological Association in the 1960s which states that psychiatrists should refrain from diagnosing public figures, and the American Medical Association code of ethics which likewise discourages armchair diagnosis (rule established in 2017).

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