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.” August 2024 Untitled Letter to Mirati Therapeutics Inc.

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Clinic Provider IT Complication 59

FDA Law Blog

JUNE 29, 2022

The Expedited Programs Guidance describes situations warranting rescission as when emerging data no longer support the BTD, another product gains traditional approval and evidence is not provided that the designated drug may demonstrate substantial approval over the approved product, or when the program is no longer being pursued.

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IT Clinic Provider Medical 52

FDA Law Blog

JUNE 23, 2021

As someone who studied in the fields of public health, medical sociology, and biomedical ethics, I was impressed with how quickly the pharmaceutical and biotechnology arena caught up with what took many decades to occur in the context of the physician-patient relationship.

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Patients Patient-Centered Clinic IT 52

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 31, 2022

The United States filed a Complaint against Texas entities Zarzamora Healthcare LLC, Rite-Away Pharmacy and Medical Supply #2– and its Pharmacist-in-Charge (PIC), and part owner. Because Plaintiff has provided no notice to defendants, the Court is precluded from issuing any preliminary injunction. 21 U.S.C. § 21 U.S.C. §

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Government IT Provider Healthcare 40

GeriPal

MAY 18, 2023

Summary Transcript Summary Hot off the press is a brand spanking new updated 2023 AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. The Beers Criteria is one of the most frequently cited reference tools in geriatrics, detailing potentially inappropriate medications to prescribe to older people.

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Medical IT Patients Clinic 97

Physician's Weekly

JUNE 22, 2025

These included how well physicians demonstrated respect, listened to individuals, explained information, and spent enough time with them. Similarly, listening was rated lower (β = −0.286, 95% CI = −0.391 to −0.181, P = 0.001), as were explanations provided by clinicians (β = −0.133, 95% CI = −0.267 to −0.000, P = 0.050).

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Individual Insurance Education Medical 59

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

FDA Law Blog

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. FDA began an initial VMSR pilot program in 2015. The draft guidance provides information about the VMSR Program eligibility and scope, reporting conditions, and the reporting process.

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Medical Manufacturing Individual Provider 59

GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

APRIL 13, 2023

Check out some of their recent work, including: Dr. Holt-Lunstad’s and Dr. Perissinotto’s powerful perspective piece in the New England Journal of Medicine which provides a clinical framework for addressing loneliness and social isolation. We’ll talk about is it in medical practice yet? And then the second one in 2015.

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IT Community Patient-Centered Medical 99

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) ™. Jessie: Exactly.

Illness 136

Illness Patient-Centered Screening Clinic 136

GeriPal

JANUARY 11, 2024

Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). What’s up with Medical aid in dying in Canada? Eric: So again, the topic is going to be medical aid in dying in Canada. The MAID issue then came on the table in Canada after the 2015 Supreme Court ruling in Carter v.

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Illness IT Medical Provider 144

GeriPal

DECEMBER 8, 2022

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. And which of those experiences would you like to share with us that we could then write into a story that we’ll share with providers?

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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. We provide critical education. We provide critical conversations with colleagues and families to coordinate transition planning.”

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Patient-Centered Hospital Patients IT 132

GeriPal

DECEMBER 15, 2022

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. And which of those experiences would you like to share with us that we could then write into a story that we’ll share with providers?

IT 105

IT Patient-Centered Healthcare Illness 105

GeriPal

DECEMBER 14, 2023

On this podcast we talk about her paper in JAMA Internal Medicine which studied three hospitals that varied in the intensity of care they provided to seriously ill patients. And so for me, I started off at one particular institution for medical school and went to another and noticed quite a few differences.

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Hospital IT Patient-Centered Patients 125

GeriPal

JUNE 30, 2022

Alex: Today, we are delighted to welcome Joel Weissman, who is a health services researcher and deputy director and chief science officer for surgery at the Center for Surgery and Public Health at Harvard Medical School. Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

GeriPal

AUGUST 25, 2022

I had looked at a research article that had recently evaluated the prevalence of private equity transactions in the hospice market and noted that there was a pretty substantial uptick in the past decade, and really over the course of say around 2015 to 2019. Basically, there’s a lot of variation amongst hospice providers.

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Families Family IT Patients 106

FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.)

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Manufacturing Consulting Healthcare Professional Vaccination 40

GeriPal

MARCH 3, 2022

Julien, let’s start off with, congratulations by the way and Lauren too, the CHEST paper that just got published on Trends in Geriatric Conditions Among Older Adults in the ICU between 1998 and 2015. It was this slow build, I would say. Julien: He basically had an end of life care discussion with this patient.

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Patient-Centered Patients IT Hospital 96

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 Community 129

GeriPal

JULY 25, 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.

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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.” 2015, 2016.

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Patient-Centered IT Families Family 125

GeriPal

JANUARY 5, 2023

No matter what your position on medical aid in dying (I’m ambivalent) or abortion (I’m pro-choice), this is a bioethics podcast, and I hope that we can all agree that the ethical issues at stake deserve a critical re-think. Today, medical aid in dying is legal in some 10 states, and illegal in others. . Summary Transcript Summary.

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Provider Medical Hospital Patient-Centered 19

FDA Law Blog

NOVEMBER 8, 2023

The rule established a new category of OTC hearing aids for individuals with mild to moderate hearing loss, allowing them to purchase hearing aids directly from stores or online retailers without the need for a medical examination, prescription, or fitting adjustment by an audiologist.

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Utilities IT Engineering Appointment 64

Physicians News Digest

APRIL 3, 2025

Survey data gathered by AHRQ provides much of what is known about hospitalizations for motor accidents, measles, methamphetamine, and thousands of other medical issues. Medical errors caused by missed diagnoses, drug errors, hospital infections, and other factors kill and maim tens of thousands of Americans each year.

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Patient-Centered Hospital Diagnose Medical 52