FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software. Premarket Approval or De Novo pathways). FDA’s position is, however, only one side of the story.

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FDA Law Blog

JANUARY 26, 2022

In defending the complete broadcast, Lilly called out similar elements from each of the individual components as demonstrating its intent to have all three viewed sequentially. By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming!

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IT Education Utilities Patient-Centered 40

FDA Law Blog

FEBRUARY 27, 2024

FDA also approved two NDAs on the same first day for micafungin (MYCAMINE)—NDA 021506 for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation, and NDA 021754 for the treatment of esophageal candidiasis. FDA-2015-E-2602, FDA-2015-E-2604, FDA-2015-E-2619, and FDA-2015-E-2615.

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FDA Law Blog

AUGUST 11, 2024

In other words, individuals may not be as vigilant about avoiding allergens if they only hear the benefits of AUVI-Q without understanding there may be safety consequences as well. Honestly, we are pretty shocked that this social media post slipped through the review committee.

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Pamela Wible MD

JUNE 20, 2025

Psychiatrists define burnout as a job-related dysphoria in an individual without major psychopathy—meaning you’re normal; your job is killing you. Since that 2015 conversation, I’ve been debunking burnout as a victim-blaming buzzword that prolongs physician agony by avoiding the real issue leading to physician despair.

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GeriPal

JUNE 19, 2025

Noelle Marie 01:24 I think it really speaks a lot to my own personal journey and I’m pretty sure a lot of trans and gender diverse individuals also resonate with and it really speaks about our transition, celebrating our authentic selves, how society views us and how we view ourselves when we stand in front of a mirror.

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Individual Community IT Chronic Condition 81

GeriPal

DECEMBER 15, 2022

Along the way we address: Is this degree of slowed cognitive decline meaningful to patients or care partners? Heather: I do Alex, and I’m so happy to have this song request, it’s called The Eye by Brandi Carlile, which comes from a quite old 2015 album called The Firewatcher’s Daughter. Summary Transcript Summary.

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IT Patient-Centered Healthcare Illness 105

GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. 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. Tasce: I do. Tasce: Yes.

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Patient-Centered IT Healthcare Medical 96

GeriPal

MAY 18, 2023

We’ve invited two members who helped update the criteria including Todd Semla and Mike Steinman. We discuss a little history of the Beers criteria, including the original Beers Criteria that was published by the late Dr. Mark Beers, and how it has evolved over the last three decades. Alex: We’re having Beers. We’ll learn about that.

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GeriPal

JANUARY 18, 2024

We start off the conversation by talking about whether patients with cancer and cancer pain are really that different, and their paper that was just published on January 11 th in JAMA Oncology showing that substance use disorder is not uncommon in individuals with cancer. Maybe we’ll get to talking about that today.

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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. It wasn’t until the end that the best term emerged – storycatching. What’s in a story?

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Patient-Centered Illness Healthcare IT 115

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. The patient’s capacity to make decisions was marginal, and his sons were shouldering much of the responsibility.

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Patient-Centered Hospital Patients IT 132

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? Welcome back, Ashwin. Ashwin Kotwal: Excited to be back. Eric: Now, it’s interesting. Alex: Great. All right.

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IT Community Patient-Centered Medical 99

GeriPal

JUNE 30, 2022

You have a patient with dementia severe enough that she cannot recognize relatives. A huge part of this decision rests on (1) her previously stated wishes, values, and goals (prior to the onset of dementia); and (2) the outcomes of surgery for patients with dementia. Summary Transcript Summary. She falls and breaks her hip.

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Patient-Centered Complication Patients IT 101

GeriPal

DECEMBER 14, 2023

More recently Sharon Kaufman ‘s book And a Time to Die described the ways in which physicians, nurses, hospital systems, and payment mechanisms influenced the hour and manner of patient’s deaths. This field is not new. Liz: Well, some aspects of this paper around clinical momentum and things around defaults and that sort of thing.

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Hospital IT Patient-Centered Patients 125

GeriPal

AUGUST 25, 2022

Second, Hospice was originally designed for patients with advanced cancer, but the fastest growing admitting diagnosis is dementia. Krista Harrison found , to her surprise, that caregivers of people with dementia who died rated hospice as well as similar patients without dementia who died on hospice. AlexSmithMD. Transcript.

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Families Family IT Patients 106

GeriPal

MARCH 3, 2022

This idea that for critically ill patients in the ICU, geriatric conditions like disability, frailty, multimorbidity, and dementia should be viewed through a wider lens of what patients are like before and after the ICU event was transformative for our two guests today. GeriPal podcast with Linda Fried on frailty. Alex: (Singing).

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Patient-Centered Patients IT Hospital 96

GeriPal

JANUARY 11, 2024

In further contrast to the United States, MAID in Canada is almost entirely administered by a clinician, whereas in the United States patients must self administer. Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). Four percent. It is the slippery slope made real. It was amazing.

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Illness IT Medical Provider 144

GeriPal

JUNE 29, 2023

He taught us a little about the different flowers and plants, and along the way a little about why he does what he does. One story that Allan told perfectly sums this up. Eric: And in the end, we have a very special part where we actually get a tour of their gardens outside of the hospice unit. So take a listen.

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FDA Law Blog

FEBRUARY 16, 2023

Many states already have standing orders that allow for the dispensing of naloxone without an individual prescription and other public health initiatives to increase naloxone access. February 2023 Advisory Committee for NNS Rx-to-OTC Switch Narcan Nasal Spray was originally approved by FDA in November 2015 (NDA 208411).

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FDA Law Blog

AUGUST 21, 2023

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. Koblitz & Deborah L. More than a few have taken far longer—literally decades. But we digress.

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Manufacturing Consulting Healthcare Professional Vaccination 40

GeriPal

DECEMBER 7, 2023

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US.

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Healthcare IT Education Community 129

GeriPal

JULY 25, 2024

The PPS is one of the most widely used prognostic tools for seriously ill patients, but the prognostic estimates given by the PPS are based on data that is well over a decade old. Why do this? Widera and Smith have no relationships to disclose. Guests Kara Bischoff, James Deardorff, and Elizabeth Lilley have no relationships to disclose.

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Families Family Patient-Centered Patients 106

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Malaz: I love it.

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Patient-Centered IT Families Family 125

GeriPal

JANUARY 5, 2023

We start by talking with Robert Brody, an internist who recalls physicians helping patients die during the height of the AIDS epidemic in San Francisco. Robert was first asked by one of his own patients for assistance in dying in 1991, far before aid in dying was legalized in California in 2016. I got it the second time. Okay, good.

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Provider Medical Hospital Patient-Centered 19

FDA Law Blog

SEPTEMBER 14, 2021

The most far reaching drug pricing provision of Subtitle E is an amendment to the Social Security Act to establish a Fair Price Negotiation Program applicable to Medicare Parts B and D as well as group and individual health plans in the commercial market. the amount Part D plans pay pharmacies for the drugs). 8126 with a lower MFP.

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Manufacturing Insurance Government Patients 52

Physicians News Digest

APRIL 3, 2025

The episodes turned both women into advocates for patients and spurred research that made American health care safer. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals. It also has published tools and guidelines to enhance patient safety.

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