FDA Law Blog

AUGUST 11, 2024

FDA’s stated concern from a public health perspective is that the omission of risk information “fails to provide material information about the consequences that may result from the use of Auvi-Q and creates a misleading impression about the drug’s safety.” The second Untitled Letter was issued to Mirati Therapeutics Inc.

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Clinic Provider IT Complication 59

FDA Law Blog

FEBRUARY 27, 2024

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. FDA-2015-E-2602, FDA-2015-E-2604, FDA-2015-E-2619, and FDA-2015-E-2615. 351, 355-56 (1985). l56(d)(1).

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Patients IT Provider Individual 59

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. And in this case the presentation would be compliant whether each component was shown individually, or, when combining all three sequentially.

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IT Education Utilities Patient-Centered 40

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 82

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: Yes. Taylor Swift.

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Patient-Centered IT Healthcare Medical 96

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 116

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. AMA PRA Category 1 credit(s) ™. And so, let’s help them.

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Illness Patient-Centered Screening Clinic 137

GeriPal

MAY 18, 2023

So the intention of the AGS Beers Criteria is to provide information primarily to clinicians, although to other audience as well, but medications that we consider to be potentially inappropriate in older adults. So we want to alert clinicians as well as patients and policy makers to the presence of these drugs. Mike: Thank you.

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Medical IT Patients Clinic 97

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 133

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. So I would love to hear.

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IT Patient-Centered Healthcare Illness 106

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? And then the second one in 2015. I moved to Baltimore in 2015 and did clinical fellowship in geriatrics.

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IT Community Patient-Centered Medical 100

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.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

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 107

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. We discuss the moral distress that clinicians felt including, as one physician put it, a sense of your soul being ripped out.

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Hospital IT Patient-Centered Patients 126

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.

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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. The MAID issue then came on the table in Canada after the 2015 Supreme Court ruling in Carter v. AMA PRA Category 1 credit(s) ™. But that was separate from MAID.

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Illness IT Medical Provider 144

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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Supply Chain Healthcare Professional Community IT 64

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. A recent state law failure-to-warn case in the SDNY makes that very point. 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. And we have gone from 250 members at the end of 2015 to about 26,000 right now across the United States and a number of chapters that have grown. Voting and emailing congress to advocate for systemic change (e.g.

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Healthcare IT Education Hospital 130

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. It is appropriate for all patient populations, and it is developed specifically for the palliative care and hospice populations. Why do this?

Families 108

Families Family Patient-Centered Patients 108

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.” 2015, 2016.

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Patient-Centered IT Families Family 126

GeriPal

JANUARY 5, 2023

“Typically when we think about conscience in medical ethics we think about it in terms of a negative claim of conscience, where a clinician refuses (or objects) to provide care. Lisa was writing about providing abortion care, but she just as easily could have been writing about providing medical aid in dying in states where it is illegal.

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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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Patient-Centered Hospital Diagnose Medical 52